Introduction – Interventional Radiology Equipment Classification in India
The classification of Interventional Radiology Products plays a vital role in ensuring their safety, efficacy, and regulatory compliance. These devices, which include cameras, scanners, nuclear probes, ultrasonic monitors, X-ray systems, and more, are important for accurate diagnostics and therapeutic procedures. The CDSCO classifies these devices under the Medical Device Rules 2017 in India, using a risk-based approach to assign each device into appropriate risk categories, ensuring compliance with established safety standards. This helps streamline the medical device registration in India and facilitates better market access for manufacturers and importers.
India is Updating Existing Risk-Based Classifications for Medical Devices |
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On January 6th, 2025, India's CDSCO published a draft annexure under notification MED-16014(12)/1/2022-eoffice, adding 139 new devices to the existing list of Interventional Radiology Products. This significant update also reclassified several existing devices, reflecting advancements in technology and regulatory requirements. Specifically, 17 devices have been reclassified from Class A to Class A (Self Notified), 3 devices have been moved to a higher risk class, and 1 device has been moved to a lower risk class.The Updated CDSCO medical device rules in India ensure alignment with international standards and facilitate a robust regulatory framework for medical device compliance in India. The complete list of updated classifications for Interventional Radiology Products, along with their intended use and revised risk categories, is provided in this document for easy reference. |
The table below provides the updated classifications for Interventional Radiology Products, including their intended use and revised risk categories. Newly added devices and devices with updated classifications are highlighted in dark grey for easy identification.
Table: CDSCO Interventional Radiology Equipments Classification
| S.No | Device name as per Medical Device Rules 2017 in India | Intended Use | Risk Class |
| 1 | Nuclear whole body counter | A nuclear whole body counter is a device intended to measure the amount of radionuclides in the entire body. | A |
| 2 | Bone densitometer | A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. | C |
| 3 | Bone sonometer | A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. | B |
| 4 | Emission computed tomography system | An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data | C |
| 5 | Fluorescent scanner | A fluorescent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain x-rays or low-energy gamma rays. | C |
| 6 | Nuclear rectilinear scanner | A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient. | A |
| 7 | Nuclear tomography system/nuclear medicine system | A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. | C |
| 8 | Nuclear uptake probe | A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region | A |
| 9 | Radionuclide dose calibrator | A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients | B |
| 10 | Nuclear anthropomorphic phantom | A nuclear anthropomorphic phantom is a human tissue facsimile that contains a radioactive source or a cavity in which a radioactive sample can be inserted. It is intended to calibrate nuclear uptake probes or other medical instruments | A |
| 11 | Nuclear flood source phantom | A nuclear flood source phantom is a device that consists of a radiolucent container filled with a uniformly distributed solution of a desired radionuclide. It is intended to calibrate a medical gamma camera-collimator system for uniformity of response | A |
| 12 | Radionuclide rebreathing system | A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere). | C |
| 13 | Non Fetal ultrasonic monitor | A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion | B |
| 14 | Ultrasonic pulsed doppler imaging system | An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. | B |
| 15 | Ultrasonic pulsed echo imaging system | An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. | B |
| 16 | Diagnostic ultrasonic transducer | A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. | B |
| 17 | Angiographic x-ray system | An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. | C |
| 18 | Diagnostic x-ray beam-limiting device | A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam | C |
| 19 | Cine or spot fluorographic x-ray camera | A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier | C |
| 20 | Electrostatic x-ray imaging system | An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. | C |
| 21 | Image-intensified fluoroscopic x-ray system | An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. | C |
| 22 | Non-image- intensified fluoroscopic x-ray system | A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. | C |
| 23 | Spot-film device | A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy | B |
| 24 | Diagnostic x-ray high voltage generator | A diagnostic x-ray high voltage generator is a device that is intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes. | B |
| 25 | Mammographic x-ray system | A mammographic x-ray system is a device intended to be used to produce radiographs of the breast | C |
| 26 | Full-field digital mammography system | A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast | C |
| 27 | Photofluorographic x-ray system | A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body | C |
| 28 | Pneumoencephalographic chair, non powered | A pneumoencephalographic chair is a chair intended to support and position a patient during pneumoencephalography (x-ray imaging of the brain). | B |
| 29 | Radiographic film cassette/X-ray cassette | A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film | B |
| 30 | Radiographic film/cassette changer | A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure. | B |
| 31 | Radiographic film/cassette changer programmer | A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography. | B |
| 32 | Automatic radiographic film processor | An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. | C |
| 33 | Radiologic quality assurance instrument | A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device. | A |
| 34 | Radiographic anthropomorphic phantom | A radiographic anthropomorphic phantom is a device intended for medical purposes to simulate a human body for positioning radiographic equipment. | A |
| 35 | Radiological computer-assisted diagnostic software for lesions suspicious of cancer | A radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing prescription device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. | C |
| 36 | Medical image analyzer/Medical image interpretive application software | Medical image analyzers, including computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, is a prescription device that is intended to identify, mark, highlight, or in any other manner direct the clinicians’ attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. This device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. This device is not intended to replace the review by a qualified radiologist, and is not intended to be used for triage, or to recommend diagnosis. | B |
| 37 | Radiological computer aided triage and notification software | Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. | C |
| 38 | Full-body MRI system, permanent magnet | A general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly. | C |
| 39 | Full-body MRI system, resistive magnet | A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). It includes a resistive magnet assembly. | C |
| 40 | Full-body MRI system, superconducting magnet | A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly. | C |
| 41 | Foetal cardiac monitor | A mains electricity (AC-powered) device designed to detect, measure, and display foetal heart activity during the perinatal period. | C |
| 42 | Foetal Doppler system | A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman’s abdomen.The device aids in determining foetal viability. | C |
| 43 | Flexible ultrasound colonoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. | B |
| 44 | Flexible ultrasound duodenoscope | An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy. | B |
| 45 | Flexible ultrasound gastroduodenoscope | An endoscope with a flexible inserted portion, combined with an ultrasound probe,intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. | B |
| 46 | Flexible ultrasound laparoscope | An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. | B |
| 47 | Flexible ultrasound bronchoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. | B |
| 48 | Bladder ultrasound imaging transducer | An ultrasound imaging transducer assembly specifically designed to be positioned within the bladder either manually or under endoscopic guidance that steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. | B |
| 49 | Blood flowmeter catheter, Doppler | A flexible tube intended to be inserted into the lumen of a blood vessel to determine blood-flow velocity by measuring the ultrasonic frequency shift between transmitted and reflected signals (Doppler principle). | C |
| 50 | General-purpose ultrasound imaging system | A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). | B |
| 51 | Nuclear whole body scanner | A nuclear whole body scanner is a device intended to measure and image the distribution of radionuclides in the body by means of a wide-aperture detector whose position moves in one direction with respect to the patient. | C |
| 52 | Nuclear electrocardiograph synchronizer | A nuclear electrocardiograph synchronizer is a device intended for use in nuclear radiology to relate the time of image formation to the cardiac cycle during the production of dynamic cardiac images | B |
| 53 | Diagnostic x-ray tube housing assembly | A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. | B |
| 54 | Transilluminator for breast evaluation/Breast transilluminator (Diaphanoscope) | A transilluminator, also known as a diaphanoscope or lightscanner, is an electrically powered device that uses low intensity emissions of visible light and near-infrared radiation (approximately 700-1050 nanometers (nm)), transmitted through the breast, to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities. | C |
| 55 | Angiography contrast medium injection system, battery-powered | A battery-powered assembly of devices designed to inject contrast media through a small catheter and into the vascular system for angiographic procedures (e.g., examination of the coronary and renal arteries, and great vessels and vasculature of the heart, brain, abdominal organs, and extremities). | C |
| 56 | Angiography contrast medium injection system, line-powered, mobile/stationary | An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for angiographic procedures (e.g., examination of the coronary and renal arteries, and great vessels and vasculature of the heart, brain, abdominal organs, and extremities). It consists of mains electricity (AC-powered) electromechanical injectors (electric motor connected to a jackscrew that moves a syringe piston) with syringes capable of delivering media with the pressure, flow range, and volume required for angiographic studies, and may be stationary or mobile (e.g., on a wheeled pedestal). Some types can synchronize media delivery with the electrocardiographic cycle and/or the x-ray generator. | C |
| 57 | Automatic- aperture-control diagnostic x-ray system collimator | A standard, diagnostic x-ray beam-limiting and shaping device that includes an automatically controlled motorized shutter mechanism. It is designed to adjust the shutters so that the x-ray beam shape matches the size of the film cassette in the holder and is attached to the beam exit port of a diagnostic x-ray system tube housing assembly. It is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas. | B |
| 58 | Axial length measuring ultrasound system | An ophthalmic device that uses ultrasound technology to measure axial length of the eye (distance along the axis of the eye between the anterior corneal surface and the anterior retinal surface). | B |
| 59 | Basic diagnostic x-ray system table, non- powered | A non-powered table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It is not intended for use during interventional radiology/surgery. | B |
| 60 | Basic diagnostic x-ray system table, powered | A powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It is not intended for use during interventional radiology/surgery. | B |
| 61 | Basic/General- purpose diagnostic x-ray system, mobile/stationary /portable | An assembly of devices that comprise an analogue general-purpose mobile diagnostic x-ray system used in a variety of routine x-ray imaging applications. It is typically an x-ray film based system using analogue or analogue-to-digital techniques for image capture and display. It is commonly used for bedside imaging and for interventional and intraoperative imaging. | C |
| 62 | Bladder volume ultrasound imaging system | An assembly of portable, battery-powered devices designed for the extracorporeal ultrasound measurement of the male or female urinary bladder volume. It typically consists of an electronic measuring and imaging display unit with a connected ultrasound transducer which together reproduce digitized data of the bladder, typically bladder volume and post-void residual (PVR), and images. It will generate ultrasound pulses, direct them to the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic three- dimensional (3-D) data/images. It is used in the diagnosis of urinary retention and postoperative urinary retention (POUR). | B |
| 63 | Body-orifice ultrasound imaging transducer cover | A sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. | B |
| 64 | Body-orifice ultrasound imaging transducer cover, image- enhancement | A sheath containing an extraluminal pocket/balloon portion intended to cover an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum), to both protect the transducer and improve image quality. The balloon portion is intended to, when filled with an aqueous solution (e.g., saline), displace air and provide an adjustable interface between the transducer and the anatomy of interest (e.g., prostate) to improve imaging. | B |
| 65 | Cardiovascular MRI system, Permanent magnet | A magnetic resonance (MR) diagnostic imaging device specifically designed to visualize the cardiovascular system. The device uses a permanent magnet, and can be stationary, mobile, or portable. The device is equipped with a patient support bed specifically designed to control the positioning of the patient’s body, to optimize visualization of the cardiovascular system at rest and during exercise stress tests, or during interventions. | C |
| 66 | Cardiovascular MRI system, resistive magnet | A magnetic resonance (MR) diagnostic imaging device specifically designed to visualize the cardiovascular system. The device uses a resistive magnet and is equipped with a patient support bed specifically designed to control the positioning of the patient’s body, to optimize visualization of the cardiovascular system at rest and during exercise stress tests, or during interventions. | C |
| 67 | Cardiovascular MRI system, Superconducting magnet | A magnetic resonance (MR) diagnostic imaging device specifically designed to visualize the cardiovascular system. The device uses a superconducting magnet, and can be stationary, mobile, or portable. The device is typically equipped with a patient support bed specifically designed to control the positioning of the patient’s body, to optimize visualization of the cardiovascular system at rest and during exercise stress tests, or during interventions. | C |
| 68 | Cardiovascular ultrasound imaging system | An assembly of mains electricity (AC- powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three- dimensional (3-D) images. May be used in intraoperative surgical planning. | C |
| 69 | Cephalometric digital X-ray sensor | A sensor for a digital X-ray image processing system combined with a diagnostic X-ray system designed for visualization and size measurement of the human head (skull) using radiation. The sensor consists of the charge coupled devices (CCDs) and contains a sensor driving circuit and signal processing circuit | C |
| 70 | Computed radiography digital imaging scanner | A device/device assembly designed to be used with an analogue x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing; it is not dedicated to dental use. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., a printer). | B |
| 71 | Computer system for ultrasound imaging system | A mainframe computer, a personal computer (PC) or a PC-based platform, and related hardware, software and operating system software dedicated used for controlling and monitoring performance of a diagnostic ultrasound system and related image processing, display and analytical functions. | B |
| 72 | Contrast medium conservation system (Contrast management system) | An assembly of electromechanical devices that controls the amount of contrast agent supplied to the syringe/injector portion of the contrast medium injector system. It is designed to optimise the use of injectible contrast agents in order to prevent unnecessary waste of contrast media during and/or between patient procedures. | B |
| 73 | Contrast medium injection system administration set | A collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer. This is a disposable device. | B |
| 74 | Contrast medium injection system control unit | A mains electricity (AC-powered) electronic device that may be a component of a contrast medium injector system and designed to initiate and terminate the operation of a contrast medium injection procedure from a remote location (e.g., the shielded operators control room). | C |
| 75 | Contrast medium injection system hand controller kit | A collection of non-powered devices designed to be used and interact with a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of a high pressure line, a high pressure stopcock, and a hand-held manual controller used to stop and start the contrast medium injection system instantaneously. | C |
| 76 | Contrast medium injection system syringe | A component of a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It is primarily an exchangeable plunger-in- barrel chamber for the medium/solution; the movement of the plunger (piston) is controlled by the contrast medium/solution injector. This is a reusable device. | B |
| 77 | Coronary optical coherence tomography system | An assembly of optical and computer-based devices that use a broad-bandwidth light beam for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. The system includes an optical-imaging catheter which is connected to the console for transmission of the images from the intravascular site. The system may be used during interventional cardiology, radiology, or diagnostic angiography. | C |
| 78 | Coronary optical coherence tomography system catheter | A sterile flexible tube with an extremely fine working end that houses an optical fibre and imaging lens intended to be transcutaneously introduced into the coronary vasculature to perform coronary optical coherence tomography (OCT). The proximal end of the device connects to a coronary OCT console for the transmission of high-resolution images (e.g., 5 to 40 micron) of the coronary intravasculature. | D |
| 79 | CT contrast medium injection system, stationary/mobile | An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). The system may synchronize media delivery with the x- ray generator during CT scanning. | C |
| 80 | Dental computed radiography digital imaging scanner | A device/device assembly dedicated to dental use and designed to be used with an analogue dental x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., a printer). | B |
| 81 | Dental digital X- ray imaging sensor | A digital dental X-ray sensor used in the oral cavity, in combination with a general- purpose dental X-ray imaging device. The sensor consists of a CCD or other components, and comprises a sensor drive circuit and a signal processing circuit. | B |
| 82 | Dental x-ray film, screen | A screen x-ray film specifically sized and designed for use with dental x-ray systems. It is designed to be sensitive primarily to the wavelengths of light emitted from an image intensifying screen. May be used endorally/extraorally. | B |
| 83 | Diagnostic x-ray digital imaging conversion system | An assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a filmless cassette-size digital detector (e.g., indirect flat panel detector); and 2) additional processing/viewing hardware [e.g., a central processing unit (CPU) with integrated software and a monitor]. It does not contain the controls for the direct operation of an x- ray imaging system. | B |
| 84 | Diagnostic x-ray digital imaging system workstation | A freestanding component of an x-ray-based diagnostic digital imaging assembly intended to associate X-ray/CT/fluoroscopic images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. It may be intended to be integrated as part of a radiology picture archiving and communication system (PACS) and does not have controls for direct operation of the imaging system. | B |
| 85 | Digital angiographic x- ray system, mobile/stationary /portable | An assembly of devices intended to visualize and optimize the macroscopic or quantitative evaluation of the anatomy and function of the blood and lymphatic systems in the heart, brain, or other organs. The device uses digital technology for real-time image capture, display, and manipulation, and typically may have a radiographic function in addition to fluoroscopic function. | C |
| 86 | Digital basic diagnostic x-ray system, mobile/portable/stationary | An assembly of devices that comprise a digital general-purpose mobile diagnostic x- ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. It is commonly used for bedside imaging and for interventional and intraoperative imaging. | C |
| 87 | Digital cephalometric x- ray system | An x-ray system designed to generate and control x-ray beams and to record the absorption patterns of x-rays passing through a patient’s head (skull). It is used for: 1) radiographic visualization and measurement of the dimensions of the human head, e.g., abnormal structures of the skull; 2) orthodontic assessment of the relationship of the teeth to the jaws and the jaws to the rest of the facial skeleton; 3) assessment airway and other soft tissue structures. | C |
| 88 | Digital general- purpose fluoroscopic x-ray system, mobile/portable/ stationary | A general-purpose diagnostic fluoroscopic x- ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It is also intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x- ray contrast medium. Images can be both real-time and delayed formats. | C |
| 89 | Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray (CR cassette) | A device that includes both a digital imaging cassette and a phosphor plate (also known as screen) intended to receive radiation by a diagnostic x-ray system, to record a patient radiation pattern during a non-dental procedure. The device is then transferred, with the cassette shielding the plate from environmental light, to a computed radiography (CR) scanner for insertion to produce the digital image of the patient. | B |
| 90 | Digital intraoral dental x-ray system, mobile/portable/stationary/hand- held | A diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging. | C |
| 91 | Digital mammographic x-ray system, mobile/stationary /portable | An assembly of devices specifically designed to be installed permanently and intended to compress and image the breast. It is primarily used to optimize the capability of users to visually evaluate x-ray film images representing the anatomy and function of blood and lymphatic vessels within the human breast. It may be used for breast cancer screening and in conjunction with the placement of biopsy markers and stereotactic biopsy and lesion localization equipment requiring x-ray guidance. | C |
| 92 | Digital panoramic/tomographic dental x-ray system (OPG) | A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. | C |
| 93 | Digital uro-gynaecological fluoroscopic x-ray system | A diagnostic x-ray system with real-time fluoroscopic capabilities specifically designed for use in urological and/or gynaecological surgical and interventional procedures requiring real-time visualization of the pelvic area. | C |
| 94 | Doppler blood-flow measurement ultrasound system | A portable or stationary ultrasonic device (invasive or noninvasive) that does not produce 2-dimensional or 3-dimensional images, and is intended to be used for determining various blood-flow related parameters of the heart, artery, or vein. The device is used to output audible data, or display the Doppler shift as a function of time. | B |
| 95 | Extracorporeal ultrasound imaging transducer, hand-held (ultrasound probe) | A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient’s body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device. | B |
| 96 | Extremity MRI system, permanent magnet | A diagnostic magnetic resonance imaging (MRI) system employing permanent magnet technology specifically designed to image only the head and neck or limbs. | B |
| 97 | Extremity MRI system, superconducting magnet | A diagnostic magnetic resonance imaging (MRI) system employing superconducting magnet technology specifically designed to image only the head and neck or limbs. | B |
| 98 | Flat panel radiography and fluoroscopy system | A digital image acquisition system in which X- rays passed through a human body are captured by an X-ray flat panel detector, and digital output signals are supplied to an image processing device to receive digital images. If necessary, image processing technology including gamma correction and edge enhancement are applied to digital images. Image data are either recorded on the media, or output to a server or other external devices for recording. | C |
| 99 | Flexible endoscopic ultrasound imaging transducer | A flexible, ultrasound imaging transducer assembly designed to be to be inserted through the working channel of an appropriate flexible endoscope and positioned within the gastrointestinal, respiratory or urinary tract, (i.e., application is not specific to any particular anatomy) to transmit a signal/data to another device for display. This is a reusable device. | B |
| 100 | General-purpose fluoroscopic x-ray system, mobile/portable/stationary | A general-purpose, analog diagnostic fluoroscopic x-ray system designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real- time and delayed formats. | C |
| 101 | Grid for MRI (needle guide positioner) | A grid used for position the puncture site etc. when biopsying under the magnetic resonance imaging (MRI) guide. | A |
| 102 | Hand-held intraoral dental x-ray system | A diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue imaging and digitized afterwards or by digital imaging. | C |
| 103 | Hand-held ultrasound imaging system, body-surface | A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into body orifices. | B |
| 104 | Hand-held ultrasound imaging system, rectal/vaginal | A battery-powered, hand-held device/device assembly designed to be inserted in vaginal/rectal cavity for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. | B |
| 105 | Hand-held- detector nuclear medicine system | An assembly of diagnostic devices comprising a hand-held, non-imaging system designed primarily to detect, record, quantify and analyse various radioactive emissions (gamma, alpha, beta) of injected or ingested radiopharmaceuticals, radiation emitting devices, or other materials. It is frequently used in the monitoring and detection of deep vein thrombosis (DVT), in surgical procedures requiring radionuclide localization and in some radiolabeled monoclonal antibody applications. | B |
| 106 | Head/extremity imaging MRI system | A magnetic resonance (MR) diagnostic imaging device specifically designed to visualize the head, neck, or limbs using a resistive magnet. | C |
| 107 | Hepatic ultrasound elastography system | An assembly of mains electricity (AC- powered) devices, which may include rechargeable batteries, designed to measure liver stiffness/ultrasonic attenuation of tissues based on transient elastography for the evaluation/diagnosis of hepatic disease (e.g., liver fibrosis/steatosis); it may additionally be intended to measure spleen stiffness as an adjunct evaluation. It is typically used during diagnosis of chronic liver conditions such as viral hepatitis, alcoholic hepatitis, and biliary disease, or for post-transplant evaluation. | B |
| 108 | Indirect flat panel x-ray detector | An electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system. | B |
| 109 | Integrated ultrasound/electrocardiograph/ stethoscope unit | An electrically-powered modular device intended for general medical examination using ultrasound, electrocardiograph (ECG) and auscultation modalities, with a user interface that enables synchronized data display and recording. It consists of a multi- purpose transducer designed for transmitting/receiving ultrasound and sensing sound signals, to which an ECG lead assembly can be attached, and a connected image display monitor (e.g., tablet) with dedicated software; in addition to the integrated electronic stethoscope, it may also allow connection of a stethoscope headset for the user to directly hear sounds. | C |
| 110 | Intracardiac ultrasound imaging catheter, steerable, single-use | A steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac anatomy and physiology, and visualization of other devices in the heart; it is not intended for peripheral vascular or coronary artery insertion/imaging. It is introduced percutaneously, and includes controls to allow it to be manoeuvred (steerable). It is connected to a compatible ultrasound system for transmission and display of the images. This is a single-use device. | D |
| 111 | Intracorporal ultrasound transducer contouring attachment | Intended to be used with a hand-held ultrasound imaging system transducer to provide means to replace the position of a needle guide. | B |
| 112 | Intracorporeal central nervous system ultrasound transducer/probe | An ultrasonic probe used temporarily in central nervous system surgery. It refers to a hand-held ultrasonic transducer assembly designed to be placed at the surgical site to take local images during surgery. It includes the configuration of various transducer assemblies that consist of single or multiple elements that convert voltage into an ultrasonic beam. This category includes ultrasonic transducers used for mode A, mode B, mode M, Doppler, Color Doppler (CD), and dual (combination image, Doppler or color flow) scanning. | D |
| 113 | Intraoperative ultrasound imaging transducer cover | A sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. This is a single-use device. | B |
| 114 | Intraoral dental x-ray system, mobile/portable/stationary/hand- held | A diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. | C |
| 115 | Intravascular optical coherence tomography catheter | A catheter and a guide wire used to observe a cross section of blood vessels using an optical fiber by light. For instance, optical coherence tomography visualizes internal microscopic structure of the tissues without physical invasion of the outer protective layers. This utilizes the nature of light that penetrates and is reflected at various degrees according to the type of the tissue. | D |
| 116 | Intravascular ultrasound imaging catheter, non-steerable | A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal). | C |
| 117 | Invasive vascular ultrasound system | A mains electricity (AC-powered) device assembly designed to invasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) using ultrasound/Doppler/transit time technology during procedures involving vascular surgery. It may also provide additional measurements (e.g., blood pressure, vascular resistance). It consists of a mobile (on wheels) control unit with graphical user-interface, typically placed outside the sterile field; and an attached, reusable, sterilizable probe intended to be used within the body (invasive) but not within the lumen of the blood vessel. | C |
| 118 | Invasive vascular ultrasound system probe | A hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively/intraoperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device. | C |
| 119 | Limited view field X-ray computed tomography system | A diagnostic X-ray computed tomography (CT) system equipped with a gantry designed exclusively for taking images of the area from the head to the neck or the extremities. The system is designed to have at least 1 fixed circular arrangement of multiple X-ray tubes and detectors, or designed to have an assembly where single or multiple X-ray tube(s) and detector(s) rotate around an axis at high speed within the area that the gantry can take images. Using this system, 2D or 3D images are produced. In addition, spiral CT and special radiography can be performed at multiple angles set relative to the position of the body. | C |
| 120 | Mammographic biopsy x-ray table | A powered/programmable x-ray mammography table with electronic positional controls specifically designed to position and support a patient during breast imaging examinations usually in conjunction with breast biopsy. It is made of radiolucent materials with low x-ray attenuation coefficients and typically has special openings or attachments to facilitate breast imaging. | B |
| 121 | Mammographic MRI system, Permanent magnet | A magnetic resonance (MR) diagnostic imaging device specifically designed for breast imaging. The device uses a permanent magnet, and can be stationary, mobile, or portable. The MR device for mammography is typically equipped with a dedicated patient support bed specifically for the purpose of controlling the positioning of the patient’s body to optimize visualization of the breast. | C |
| 122 | Mammographic MRI system, Resistive magnet | A magnetic resonance (MR) diagnostic imaging device specifically designed for breast imaging. The device uses a resistive magnet, and can be stationary, mobile, or portable. The MR device for mammography is typically equipped with a dedicated patient support bed for the purpose of controlling the | C |
| 123 | Mammographic MRI system, Superconducting magnet | A magnetic resonance (MR) diagnostic imaging device specifically designed for breast imaging. The device uses a superconducting magnet, and can be stationary, mobile, or portable. The MRI device for mammography is typically equipped with a dedicated patient support bed for the purpose of controlling the positioning of the patient’s body to optimize visualization of the breast. | C |
| 124 | Mammographic stereotactic biopsy system | An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. It may be a standalone unit or a unit that mounts onto an existing mammographic unit. | B |
| 125 | Mammographic x-ray system stereotactic unit | A device that can only fulfil its purpose when used together with and enhance the function of a diagnostic mammographic x-ray system. It is used to take two pictures of a breast from two different angles. On the basis of this stereoscopic picture set, it is possible to determine the exact position of a lesion in the breast and a cytological sample of this will be taken. This device or technique may be built- in to some diagnostic x-ray systems for mammography. | B |
| 126 | Mammographic x-ray system, mobile/stationary /portable | An assembly of devices specifically designed to be installed permanently and intended to compress and image the breast. It is primarily used to optimize the capability of users to visually evaluate x-ray film images representing the anatomy and function of blood and lymphatic vessels within the human breast. It may be used for breast cancer screening and in conjunction with the placement of biopsy markers and stereotactic biopsy and lesion localization equipment requiring x-ray guidance. | C |
| 127 | Manual contrast medium injection system | An assembly of devices designed for the manual-only injection of contrast media into the blood or lymphatic vessels of a patient for a diagnostic imaging procedure; it enables the operator to manually control the volume and rate of contrast media administered under pressure. The system typically consists of a graduated injection syringe, a manifold with multiple stopcocks, and a pressure transducer system used by the operator to monitor catheter-tip pressure. | B |
| 128 | Medical x-ray film, screen | A screen x-ray film specifically designed for medical diagnostic imaging applications. It is sensitive primarily to wavelengths of light emitted from an image intensifying screen or other visible light source. This film is not limited to use with x-ray imaging systems but can also be used in a variety of diagnostic imaging modalities using image intensifier technology or matrix formatters to output images, e.g., nuclear medicine or ultrasound. | B |
| 129 | MR/CT roadmap (interpretive software) | A stand alone software that allows the synchronization of live fluoroscopy images with previously acquired MRA/CTA datasets. This may be used as an aid in applications such as image-guided surgeries, calibrating the contrast medium doses, and needle guidance. | C |
| 130 | MRI contrast medium injection system, mobile/stationary | An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for magnetic resonance imaging (MRI) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using MRI). It may interface with the MRI system or a monitoring device to control timing of contrast injections; it is made entirely of non-ferromagnetically active materials for MRI compatibility. | C |
| 131 | MRI image interpretive software | An interpretive software program intended to be used to analyse magnetic resonance imaging (MRI) data (e.g., prostate MRI) to detect and localize suspected abnormalities and sometimes provide results as clinically relevant tags; it may additionally be intended for three-dimensional (3-D) model creation slice-based images (segmentation). It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format]. | C |
| 132 | MRI planner (radiotherapy planning application software) | It is a stand alone software product intended to enable a completely MRI-only workflow in radiotherapy planning. It achieves this by analyzing a dedicated MR image and generating a synthetic CT image that can replace the conventional CT in the treatment planning process. In addition, the software may also performs automated contouring of risk organs in certain anatomies. | C |
| 133 | MRI radio frequency coil | This radio frequency coil is intended to act as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is intended to be used to enhance image resolution by improving signal to noise characteristics. | B |
| 134 | MRI system application program software | It is a standalone software application that is intended to be used for viewing, post- processing and quantitative evaluation of magnetic resonance (MR) images for applications such as quantitative cardiovascular computed tomography (CT) evaluation, determination of the triglyceride fat fraction in magnetic resonance images of the liver, multi slice and gradient echo image analysis, etc. It does not drive MRI systems. | C |
| 135 | MRI system synchronizer | A physiological monitoring unit used as a component of a diagnostic magnetic resonance imaging (MRI) system, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient’s respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic MRI applications. | B |
| 136 | MRI system table, powered | A powered/programmable table designed with electronic and/or software controls to position and support a patient during magnetic resonance imaging (MRI) examinations. It is made with ferromagnetically inactive materials and may have a detachable table top, equipment supports, physiological monitors, mattresses, alarms and a patient positioning system (PPS). | B |
| 137 | MRI system workstation | A standalone image-processing workstation that is designed to be networked with one or more magnetic resonance imaging (MRI) systems. The workstation may have any type of hardware, or any type of configuration. It is not intended to control or directly manipulate the diagnostic imaging device. The device allows data transfer either on-line or off-line, and is typically situated away from the MRI operator console. It is intended to process MRI images and provide valuable information that allow decision making, evaluation or diagnosis of the patient’s pathologic conditions. | B |
| 138 | MRI-patient physiologic monitoring system | A mobile assembly of devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of infant to adult intensive care patients during a magnetic resonance imaging (MRI) procedure. | C |
| 139 | Multi-modality diagnostic x-ray system (full body CT/fluoroscopic x-ray system) | An assembly of diagnostic x-ray devices intended to acquire, display and process images from any part of the body (full-body) incorporating the techniques of more than one x-ray imaging modality, typically including real-time fluoroscopy, two- dimensional (2D) radiography, and computed tomography (CT); it is not a single-modality system. | C |
| 140 | Neurosurgical ultrasound navigation system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a neurosurgical ultrasound (US) navigation system. | C |
| 141 | Neurosurgical ultrasound navigation system optical tracking unit | A component of a neurosurgical ultrasound (US) navigation system used to track the position of all the localizers/spatial markers during intraoperative imaging and to supply the US system with valid positional data. It typically uses equidistant-placed cameras using infrared (IR) light to measure the position/placement of the reflective spheres attached to the localizers or spatial marker holders. | B |
| 142 | Noninvasive vascular ultrasound probe | A hand-operated component of a vascular ultrasound system intended to be used to measure the flow of blood noninvasively by measuring flow in underlying vasculature from the body surface pre-/post-operatively, using ultrasonic/Doppler/transit time technology. It may also be used for cross- sectional visualization/imaging. | B |
| 143 | Noninvasive vascular ultrasound system | An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat. | C |
| 144 | Nuclear medicine data processing system | A data processing system specifically dedicated for nuclear medicine. The system is used for various types of filter processing, image display, clinical analysis, management of image storage, etc. The system may have a control system for directly operating a diagnostic imaging unit. This system can deliver or receive data online or offline, and has a configuration that can provide functions such as processing, manipulating, and displaying a patient’s images and information collected with the nuclear medicine scan. | C |
| 145 | Nuclear medicine system workstation | A standalone imaging workstation specifically designed to create network connection with one or more nuclear imaging devices, such as gamma camera, PET device, and SPECT device. The workstation may have any type of hardware, or any type of configuration. The device may be regarded as a component of a picture archiving and communication system (PACS). It differs from an operator console in that the workstation does not have controls for the direct manipulation of the imaging device. | B |
| 146 | Nuclear sealed source for absorption compensation | A sealed radioisotope equipped dedicated for the correction of absorption of radiation from a diagnostic radioisotope by organs and tissues to improve quantitative capability of diagnostic imaging of the nuclear imaging system (PET or SPECT devices), thereby improving accuracy of diagnosis. | B |
| 147 | Oesophageal ultrasound imaging transducer (oesophagal endosonography probe/transducer ) | An ultrasound imaging transducer assembly enclosed in a fluid-resistant, acoustically- and electrically-insulated housing, designed to be inserted and positioned in the oesophagus to obtain ultrasound images of the heart and/or to navigate devices requiring ultrasound guidance and placement (e.g., endoscopy equipment or needle biopsy equipment). It is composed of either a single transducer element or an array of transducer elements, i.e., piezoelectric element(s), active element(s), or crystal(s), and associated damping, backing, and matching layer materials. It is reusable. | B |
| 148 | Ophthalmic ultrasound imaging transducer | An ultrasound imaging transducer that is a hand-held device moved over the intact surface of a patient’s eye during imaging applications involving the examination of the lens. It may include single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. This group of devices typically includes ultrasound imaging transducers used with A-mode scanning capabilities. This is a reusable device. | B |
| 149 | Optical coherence tomography (OCT) imaging system | An OCT (optical coherence tomography) diagnostic imaging system which diagnostically represents the images of tissue characteristics and shapes of various sites (e.g., heart, blood vessel, abdomen, lung) using near-infrared rays, without the need to obtain tissues surgically. This system may or may not contain a software package that supports the taking of both still and real-time images, and is used to diagnose anatomic abnormalities in tissues and to examine functional and anatomic features. | C |
| 150 | Optoacoustic/ultrasound imaging system | A mobile assembly of electrically-powered devices intended for imaging and analysis of soft-tissue and soft-tissue vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging. Pulsed near- infrared laser light of various wavelengths is emitted and the associated acoustic feedback (photoacoustic effect) provides complementary information regarding tissue composition/functionality based on the presence of endogenous chromophores, such as haemoglobin; this photoacoustic data can be overlaid on the associated US image. | B |
| 151 | Orthopaedic x-ray ruler | A device used in an orthopaedic clinical setting to establish an accurate measurement of length or size related to a bone structure (i.e., length, thickness, or other aspects) when this is being viewed by the surgeon during fluoroscopy. It includes a series of notches and holes that clearly show up on the x-ray image demonstrating the distances of the viewed bone. | A |
| 152 | Panoramic digital X-ray sensor | A sensor used in combination with a diagnostic digital dental X-ray imaging device that is specifically designed for panoramic imaging of teeth, jaw, and oral structures. The sensor consists of a CCD and other components, and comprises a sensor drive circuit and a signal processing circuit. | B |
| 153 | Panoramic/tomo graphic dental x- ray system (orthopantomography system) application software | An application or operating data program designed for use in, or together with a panoramic/tomographic dental x-ray system configuration. | C |
| 154 | Paranasal ultrasound probe | A reusable or single-use ultrasound transducer assembly enclosed in a fluid- resistant, acoustically and electrically insulated housing that is intended to be inserted into and positioned in the paranasal sinuses by the operator. The device is also called an endoscopic ultrasound probe or ultrasound endoscopic transducer to be used in the paranasal sinuses. The device is typically incorporated in or used in combination with a device that requires ultrasonography guidance or ultrasonic wave generation, such as an endoscopic device or a needle biopsy device. The device is composed of either a single transducer element or an array of transducer elements (also called piezoelectric elements, active elements, or crystals), damping, backing, and matching materials. | B |
| 155 | PET infusion system | An assembly of devices intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It may also be used to provide effective radiation shielding to medical personnel from Fluorine-18 (18F) radiation exposure during nuclear medicine diagnostic procedures. (Not meant for pediatric populations). | C |
| 156 | PET system | An assembly of devices comprising a diagnostic, positron emission tomography (PET) imaging system used to detect, record, quantify and analyse 511 kilo-electronvolt (keV) photon emission patterns resulting from annihilation reactions produced during the decay of positron emitting radiopharmaceuticals. It produces three- dimensional (3-D) tomographic digital cross- sectional physiological images representing distribution patterns of positron emitting radiopharmaceuticals ingested by, or injected into the patient. | C |
| 157 | PET system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a positron emission tomography (PET) imaging system configuration. A basic set of applications programs and routines is included with such computer-controlled imaging systems and they can be upgraded to correct | B |
| 158 | PET/CT system | A diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and CT portions of the system may be used independently or in combination. | C |
| 159 | PET/MRI system | A diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a magnetic resonance imaging (MRI) system for magnetic resonance images. The nuclear medicine images and the magnetic resonance images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and MRI portions of the system may be used independently or in combination. | C |
| 160 | Positron CT combined SPECT system | A system capable of performing both SPECT examination and positron CT (PET) examination | C |
| 161 | Rectal/vaginal ultrasound imaging transducer | An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device. | B |
| 162 | Software for electrocardiograph with ultrasonic diagnostic system | A software, which is designed to process data obtained from an electrocardiograph with ultrasound diagnostic system. The resultant data are provided for diagnosis, etc. This term may involve the recording media where the software is stored. | C |
| 163 | SPECT system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a positron emission tomography (PET) imaging system configuration. A basic set of applications programs and routines is included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. | B |
| 164 | SPECT system, annular detector array | An assembly of devices comprising a diagnostic, stationary, single photon emission computed tomography (SPECT) system designed exclusively for use in tomographic imaging applications. It detects, records, quantifies and analyses radionuclide emissions produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. Its imaging capabilities include static and dynamic imaging applications and three-dimensional (3-D) digital image reconstruction/display at any angle including axial, coronal and sagittal planes. | C |
| 165 | SPECT system, rotating detector head | An assembly of devices comprising a diagnostic single photon emission computed tomography (SPECT) system that is a three- dimensional (3-D) tomographic imaging gamma camera-based system used to detect, record, quantify and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation | C |
| 166 | SPECT/CT system | An assembly of diagnostic devices that comprise a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine (NM) images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The SPECT and CT portions of the system may be used independently or in combination and the images may be transferred to other systems for radiation therapy planning or additional processing. | C |
| 167 | Surgical ultrasound imaging transducer | A hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. This group of devices includes ultrasound imaging transducer assemblies used with A-mode, B-mode, M- mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device. | C |
| 168 | Thyroid-uptake nuclear medicine system | An assembly of diagnostic devices that comprise a non-imaging nuclear medicine system designed primarily for radioactive iodine related thyroid uptake measurement and analysis applications. It typically includes a multichannel analyser, computer, scintillation detector, detector support equipment, an operator’s console, video | B |
| 169 | Tissue specimen x-ray tomography system | An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. | A |
| 170 | Transoesophage al vascular ultrasound monitor | A mains electricity (AC-powered) device intended to be used for monitoring cardiac output and/or fluid status through connection to a dedicated probe, which is placed in the oesophagus to measure blood flow in the descending aorta. It is based on measuring the ultrasonic frequency shift between transmitted and reflected signals (Doppler principle) and is displayed on the monitor as a velocity/time waveform. It is typically used during a surgical procedure or in intensive care. | B |
| 171 | Transoesophage al vascular ultrasound probe | A device intended to be inserted into the oesophagus, orally or nasally, to continuously measure blood flow in the descending aorta by ultrasonic Doppler technology for assessment of cardiac output and/or fluid status. It has multiple sensors at the distal end and a connector at the proximal end. It is typically used during general anaesthesia or in intensive care. This is a single-use device. | B |
| 172 | Ultrasonic amplifier | A unit used to amplify signals transmitted from the probe of an ultrasound imaging system. This is used with an ultrasound system in the event the quality of original data transfer is lowered by the distance | B |
| 173 | Ultrasound aspiration biopsy procedure kit | A collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. This is a single-use device. | B |
| 174 | Ultrasound contrast medium, transuterine administration | A substance/formulation (e.g., solution, gel, foam) intended to be administered into the female reproductive tract, via the vagina/uterus, to enhance diagnostic ultrasound images, typically for the evaluation of the uterine cavity and/or fallopian tube patency. (Invasive devices for application not included) | A |
| 175 | Ultrasound endoscope balloon, Hevea- latex | A sterile balloon-like cap made of Hevea natural rubber latex (NRL) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher- quality ultrasound image during echo- endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. | B |
| 176 | Ultrasound endoscope balloon, synthetic polymer | A sterile balloon-like cap made of a synthetic- polymer (e.g., silicone) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. | B |
| 177 | Ultrasound imaging system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. | B |
| 178 | Ultrasound imaging system multi-transducer connection unit | An electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held US transducers so the user can conveniently switch between transducers as required. It is a unit with multiple transducer ports and is typically attached to the US imaging system stand. | B |
| 179 | Ultrasound imaging system operation software | Mainframe or personal computer (PC) based operating system software (or firmware) specific to the central processing unit (CPU) incorporated into a diagnostic ultrasound system configuration. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. | B |
| 180 | Ultrasound imaging system operator console | A device that is a component of a diagnostic ultrasound imaging system that functions as the primary control panel. It includes hardware and software that allows for image display, processing, analysis, archiving and retrieval. It typically includes the capabilities to be interfaced into a picture archiving and communication system (PACS), a local area network (LAN), a radiology information system (RIS) or a hospital information system (HIS). It contains the primary controls for the direct operation of the ultrasound system and is typically incorporated in the system design | B |
| 181 | Ultrasound imaging system tracking positioner, reusable (ultrasound transducer bracket) | A metal or plastic bracket intended to be applied to a hand-held ultrasound (US) transducer for the repeatable positioning (detach from/reattach to the same place) of an electromagnetic (EM) sensor and/or needle guide on the transducer. It may be used in conjunction with an EM device tracking system and is intended for applications involving needle guidance and tracking such as ablation, core tissue biopsy, fluid aspiration, therapeutic delivery and vascular access. (transducer and sensor are not included) | B |
| 182 | Ultrasound imaging transducer positioning unit | A unit used to position an ultrasound system imaging transducer that is inserted into the body through an endoscope. This device is an accessory to a diagnostic ultrasound imaging system and it transmits electrical signals that, after processing, will display the position of the transducer on a monitor. This unit will assist the endoscopist in the placement of the working transducer (the probe) and to allow monitoring of the movement after placement. | B |
| 183 | Ultrasound imaging transducer washer- disinfector (chemical) | A dedicated electrically-powered unit intended to be used to wash and disinfect ultrasound imaging transducers with the use of appropriate cleaning methods and chemical disinfection. It is typically a stand- alone unit with a washing/disinfecting chamber designed to accept an ultrasound imaging transducer (probe). Not intended for end disinfection. | B |
| 184 | Ultrasound system synchronizer | A physiological monitoring device used as one component in a diagnostic ultrasound system. This device produces signals which can synchronize imaging acquisition and data collection with specific measurable, physiological parameters, such as the starting point of a patient’s respiratory or cardiac cycle. It is used mainly to reduce artifacts and to increase the signal-to-noise ratio in real-time ultrasonic imaging and in video imaging. | B |
| 185 | Ultrasound- guided laser thermal therapy needle guide positioning system | An assembly of noninvasive devices intended for use during soft-tissue lesion treatment by ultrasound-guided laser thermal therapy, to provide software-based simulation of tissue thermal damage for assisting the manual positioning of percutaneous needles through which laser applicators (not included) are introduced. It consists of an electrically- powered interface/display and needle guides for attachment to a body-surface ultrasound (US) imaging probe/transducer; the system overlays real-time US images [from a separate US system] with the predicted laser thermal effect | C |
| 186 | Vascular ultrasound system control unit | A mains electricity (AC-powered) external device, which may include internal rechargeable batteries, intended to be used to indicate (visually and/or sonically) blood flow in a peripheral blood vessel, through connection to a dedicated probe/catheter (not included), using ultrasound/Doppler/transit time technology. It may be intended to locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) or to monitor blood flow in association with microvascular surgery. | B |
| 187 | X-ray film cassette, automatic film changing | A housing for x-ray film specifically designed to be used in, and work as part of, an automated x-ray film changing system. The housing is intended to be loaded with x-ray film under appropriate darkroom conditions, and is then inserted into the loading magazine of the film changing system. After exposure, it is held in a receiving magazine until the operator removes it for final processing. | B |
| 188 | X-ray film cassette, manual | A device used in medical imaging applications to shield x-ray film from exposure to room light during transport and insertion into a diagnostic imaging system, film formatter, or film processor. | B |
| 189 | X-ray film ruler | A device used in radiology to superimpose accurate measurements of length (i.e., inches or millimetres) onto an x-ray film so that these measurements remain as a permanent feature of that x-ray against the anatomical structure that has been captured. It is made of x-ray translucent material (e.g., plastic) whilst the graduations are not translucent and therefore show on the exposed x-ray film. | A |
| 190 | X-ray image intensifier | A device that converts an x-ray image into a light image, then to an electronic image and finally back to a light-based image of diminished size and increased brightness. It is primarily used in fluoroscopic, angiographic, cine-fluorographic x-ray, and digital x-ray applications as it outputs an image small enough to be coupled to cine, television or spot-film cameras. | B |
| 191 | X-ray system computer, diagnostic, general-purpose | A dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a general-purpose medical x-ray system and associated image processing, display and analysis functions. | C |
| 192 | X-ray system synchronizer | A physiological monitoring unit used as a component of a diagnostic x-ray system, e.g., fluoroscopy, angiography or general-purpose, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient’s respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic diagnostic x-ray applicṣations. It is sometimes referred to as a gated imaging accessory or trigger. | C |
| 193 | X-ray/CT combined cardiovascular diagnostic X-ray system | A system combining a diagnostic X-ray computed tomography (CT) and a diagnostic cardiovascular fluoroscopy system. | C |
Conclusion: Medical Device Compliance in India for Interventional Radiology Equipment
The recent updates to the classification of Interventional Radiology Products, as part of the evolving regulatory framework under the Medical Device Rules 2017 in India, signify CDSCO’s dedication to align with global standards. The addition of 140 new devices and the reclassification of several products emphasize the importance of staying updated with the latest developments in CDSCO medical device classification in India.
For regulatory support and assistance in navigating these updates, Morulaa’s consultancy team is available to guide manufacturers through the medical device registration in India process, ensuring compliance with the Updated CDSCO medical device rules in India. Contact us at admin@morulaa.com for more information on these updates and the registration process.