S.No

Device name

Intended use

Risk Class

1

Accelerator system chair

A seat, typically with legs, that is a component of a therapeutic accelerator system, and used to support and position a seated patient during radiation therapy treatments involving the use of either a medical linear accelerator or non-linear accelerator.

Class C

2

Accelerator system quality assurance device

An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes.

Class C

3

Alternating electric field antimitotic cancer treatment system

An assembly of portable devices designed to apply low-intensity, intermediate-frequency (100-300 kHz) alternating electric fields to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM [malignant brain tumour].

Class D

4

Alternating electric field antimitotic cancer treatment system transducer array

Alternating electric fields therapy is a novel anticancer treatment that disrupts tumor cell mitosis.

Class C

5

Alternating electric field antimitotic cancer treatment system generator

Alternating electric fields therapy is a novel anticancer treatment that disrupts tumor cell mitosis.

Class C

6

Anorectal brachytherapy system applicator, remote-afterloading

A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the rectum and/or anus.

Class C

7

Anorectal brachytherapy system applicator, manual

A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the rectum and/or anus.

Class C

8

Balloon kyphoplasty kit

A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty.

Class C

9

Bladder instillation buffer solution

A sterile buffer solution intended to be used exclusively for bladder instillation to help create an optimal environment necessary for the effective treatment of superficial bladder cancer with a chemotherapy agent.

Class B

10

Brachytherapy source spacer

A sterile, bioabsorbable device designed to separate radioactive sources of the seed type that are permanently implanted in close proximity to a selected localized tumour, to increase the distribution of radioactivity to the tumour.

Class C

11

Brachytherapy system remote-afterloading operator console

A mains electricity (AC-powered) component of a remote- afterloading brachytherapy system intended to function as the primary control panel for the remote afterloader. It typically includes hardware and software that allows for information display and/or transfer, data processing, analysis, and information archiving functions; it may also be intended to interface with other devices (e.g., radiation therapy treatment planning computer) as part of a picture archiving and communication system (PACS).

Class C

12

Breast 3-D infrared imaging/vascular analysis system

An assembly of mains electricity (AC-powered) devices intended for three-dimensional (3-D) breast imaging and breast vascular analysis, typically used with mammography screening to perform a breast cancer risk examination.

Class C

13

Breast brachytherapy system applicator, remote-afterloading

A sterile, remote-afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the breast. It is typically designed for temporary implantation within the breast and serves as a guide for computer controlled placement and removal of single or multiple radioactive sources. Included are various types of applicators such as hollow needles, tubes, or catheters, and their associated components. This is a single-use device.

Class C

14

Breast ultrasound imaging system

An assembly of mains electricity (AC-powered) devices designed for intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast.

Class C

15

Breast transilluminator

A mains electricity (AC-powered) transilluminating device with a built-in light source using low intensity emissions of visible light and near-infrared radiation (700 to 1050 nm) that is transmitted through the female breast to visualize translucent tissue for the diagnosis of cancer, or other conditions, diseases or abnormalities. This device may also be known as a diaphanoscope.

Class C

16

Breast ultrasound imaging system

An assembly of mains electricity (AC-powered) devices designed for extracorporeal ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast

Class B

17

Capsular tension ring

A circular band intended to be used to enhance the mechanical stability of a subluxated crystalline lens capsule in the presence of weak or absent supporting zonules.

Class C

18

Cervical cone knife

A surgical, manually-operated, instrument that is inserted into the vagina and designed for excising a sample of abnormal tissue, e.g., indicated by the presence of precancerous changes, from the cervix.

Class C

19

Cervical cytology scraper, single-use

A hand-held, manual, blunt surgical instrument designed to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. This is a single-use device.

Class B

20

Colonic cytology sampling set

A collection of non-sterile devices intended to collect exfoliated colonic cells (colonocytes) from the surface of human rectal mucosa for colorectal cancer investigation and/or patient screening.

Class B

21

Coronary artery brachytherapy system applicator, manual- afterloading

A sterile flexible tube intended to deliver/remove radiation therapy sources into a coronary artery, typically into the lumen of an implanted stent, as part of a manual-afterloading brachytherapy system. It is introduced into the patient and subsequently connected to the brachytherapy system source transfer device; it includes radiopaque markers to monitor the position of the radiation source. Disposable devices associated with the procedure may be included (e.g., syringe, connectors). This is a single-use device.

Class D

22

Cryosurgical set

A sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted portions.

Class C

23

Electro cancer therapy system

An assembly of devices designed for the treatment of tumours and the destruction of their cancerous cells using low-voltage direct current of small intensity delivered via electrodes placed across the affected body area.

Class C

24

Electronic clinical breast examination system

A portable assembly of devices designed to electronically measure, map, document and store information about breast lesions/masses with regard to shape, size, location, consistency/relative hardness during a clinical breast examination (CBE).

Class B

25

Electroporation therapy system

A mobile assembly of devices designed to apply electrical impulses to the tissue to enable electroporation, a phenomenon that induces alteration in the structure of cell membranes to increase their permeability and allow molecules that usually cannot enter the cell membrane, such as drugs [electrochemotherapy (ECT)] and genetic materials [electrogenetherapy (EGT)], to reach the cytoplasm.

Class C

26

Electroporation therapy system endoscopic applicator

A sterile, patient-contact component of an electroporation therapy system intended to fit onto the distal tip of an endoscope and connect to an electroporation therapy system generator to deliver electrical impulses to tissues during endoscopy as part of electroporation, a phenomenon that induces alteration in the structure of cell membranes to increase their permeability and allow molecules that usually cannot enter the cell membrane, such as drugs [electrochemotherapy (ECT)], to reach the cytoplasm.

Class C

27

Endocervical aspirator

A collection of devices designed to remove superficial tissue from the mucous membrane lining the cervical canal (endometrium) through manually- powered suction.

Class C

28

Externally-propelled flexible video colonoscope

A non-sterile endoscope with a highly flexible sleeve and distal tip intended for the visual examination of the entire adult colon [lower gastrointestinal (GI) tract].It is used for the screening of colorectal cancer and the detection of other diseases of the lower GI tract. This is a single-use device.

Class B

29

Extravascular-circulation hyperthermia system

An assembly of devices designed to produce and control heated fluids circulated within a vessel applied to the body (e.g., vest, mattress, jacket, band, pad, body wrap, catheter, probe) for systemicor localized heating to treat malignant tumours, benign growths, or other disease-related conditions.

Class B

30

Extravascular-circulation hyperthermia system applicator, extracorporeal

A vessel applied to the outside of the body (e.g., in the form of a jacket, vest, body wrap, cushion, blanket, or mattress) that incorporates tubing through which heated fluids are circulated for systemic or localized heating to treat malignant tumours, benign growths, or other disease-related conditions. The applicator typically includes a thermometry component that monitors the temperature of the applicator during operation. The applicator includes tubing, cables, and connectors that interface with the hyperthermia system’s control unit during treatments. It is typically used in an oncology department. This is a reusable device.

Class A

31

Extravascular-circulation hyperthermia system applicator, intracorporeal

A component of a hyperthermia system that typically consists of catheter-enclosed tubing which is introduced into the body either manually or endoscopically. Heated fluid is circulated through the applicator’s tubing for localized heating to treat malignant tumours, benign growths, or other disease-related conditions. The applicator (also called an interstitial applicator or probe) typically includes a thermometry component that monitors the temperature of the applicator during operation; it also includes tubing, cables, and connectors that interface with the hyperthermia system’s control unit during treatments. It is typically used in an oncology department. This is a single-use device.

Class C

32

Facial prosthesis

An externally-applied device intended to be used as an artificial substitute for parts or sections of the face [e.g., nose, eye(s), eye brows, upper lip] to help restore facial appearance. The device may be customized to meet the patient’s needs and may be held in position with magnets or screw-like implants embedded into the patient’s facial bone. It is used in cases of severe facial disfigurement typically caused by trauma (e.g., gunshot wounds) or major facial cancer surgery.

Class B

33

Fixed-aperture therapeutic x-ray system collimator

A non-automated, x-ray beam-limiting device that is a component of a therapeutic x-ray system and whose opening size/length/shutter assembly is fixed. It is used in radiation therapy applications to limit the effects of scattered radiation and to protect the patient by limiting or eliminating exposure to non- target body areas during treatment. This device is specifically designed for use with an x-ray simulation or therapeutic x-ray system.

Class C

34

Flexible fibre optic 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. Anatomical images are transmitted to the user by the device through a fibre optic bundle. This device is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.

Class B

35

Flexible fibre optic mediastinoscope

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the mediastinum (the intrapleural space located behind the sternum). It is inserted into the body through an artificial orifice created by an incision made during mediastinoscopy. Anatomical images are transmitted to the user by the device through a fibre optic bundle. This device is commonly used to examine structures such as lymph nodes during a staging evaluation of lung cancer, or to establish the diagnosis of a tumour that is localized to the mediastinum. This is a reusable device.

Class C

36

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. Anatomical images are transmitted to the user by the device typically through a fibre optic bundle or a video system, and an ultrasound probe. The probe may be built-in or inserted through a dedicated lumen so that its distal tip is positioned adjacent to that of the endoscope. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.

Class B

37

Flexible video bronchoscope, reusable

An endoscope with a flexible inserted portion for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.

Class B

38

General-purpose infusion pump, mechanical, reusable

A non-electric, mechanically-powered (e.g., a spring mechanism) device designed for the continuous or intermittent infusion of medication, typically for antibiotic therapy, chemotherapy, or pain management by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It is primarily designed to be worn by the patient during ambulation in the home. It may be used for patient- controlled analgesia (PCA), and may include mechanical indicators for flow and fluid level status. This is a reusable device.

Class C

39

General-purpose infusion pump, mechanical, single-use

A portable, non-electric, mechanically-powered device designed to be operated by healthcare professionals for dispensing a single dose of fluid medication (e.g., for antibiotic therapy, chemotherapy, analgesia). It consists of an empty reservoir intended to be filled with medication, a flow-rate regulator and a non-sterile (sterilizable) administration line intended to be connected to an infusion catheter (not included) for intravenous (IV), subcutaneous, intramuscular, or epidural administration. It may include flow and fluid level mechanical indicators and may be worn by the patient in and outside of healthcare settings. This is a single-use device.

Class C

40

Robotic Guidance system for image Guided procedures

It is an accessory to an imaging system (CT, CT- PET) intended for the spatial positioning and orientation of an instrument guide. A surgeon then manually advances one or more instruments for percutaneous image guided interventional procedures through the instrument guide. The device is not intended to make any contact with the patient.

Class B

41

Cancer diagnostic probe

A device intended for detection of breast cancer lesions of various subtypes intraoperatively by checking for tumour side margins.

Class C

42

Computer vision/Machine learning-aided software application for cancer detection

A standalone software application intended to be used to scan radiological images (X-ray, CT scan, etc.) in order to screen/diagnose for cancerous tissues using machine learning-based training models and computer vision.

Class C

43

Embolization particle, bioabsorbable

A bioabsorbable, implantable bead/microsphere intended to be used to temporarily occlude an artery supplying hyperplastic/neoplastic tissue in a variety of anatomies (e.g., liver, lung, breast, bladder, uterus, head or neck); it does not include a pharmaceutical agent. It may be used independently to create ischemia in the tissue, or as an adjuvant in combination with cytostatic agents and other antitumour drugs to help optimize intra-tumour drug accumulation for interventional radiology and visceral surgery procedures. It is typically available as an injectable solution containing numerous microspheres [e.g., degradable starch microspheres (DSM)].

Class D

44

Embolization particle, non- bioabsorbable

A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs). It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.

Class D

45

Hyperthermia system temperature probe

A device (a probe) intended to be used exclusively to monitor tissue or body temperature during hyperthermia treatments. Depending on the kind of hyperthermia system it is used with, e.g., ultrasound, radio-frequency (RF) or microwave, this probe is shielded in such a way that its operation is not affected by the energy from the hyperthermia applicator(s) in use during the treatment. This is a reusable device.

Class C

46

Implantable Vascular port/catheter

A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins.

Class C

47

Intracavitary- circulation hyperthermia system

An assembly of electrically-powered devices designed to continuously lavage body cavities (e.g., pleural cavity, peritoneal cavity, bladder lumen) with warmed fluids/chemotherapeutic agents to raise the local temperature and/or enhance the effect of drugs, typically in the treatment of malignancy. It typically includes a water heater/cooler, fluid pump, controls, inputs for monitoring temperature, a circuit with heat exchanger, fluid reservoir, and tubing connectors. Introduction/drainage catheters are connected to the system and placed in the body cavity.

Class C

48

Intraoperative gamma radiation detection system probe, reusable

An electrically-powered, invasive component of an intraoperative gamma radiation detection system intended to be introduced into the body during a surgical procedure to detect and quantify gamma radiation emitted from previously-administered radiopharmaceuticals (e.g., localized in sentinel lymph nodes), in conjunction with a dedicated control unit (not included). It is typically manipulated using surgical forceps and incorporates a crystal scintillator and photomultiplier. This is a reusable device.

Class C

49

Intraoperative tumour margin fluorescence imaging system

A set of devices designed for the excitation of an injected fluorophore (e.g., pegulicianine), and subsequent imaging of the illuminated area, to allow for intraoperative detection of residual cancerous tissue in the resection cavity following removal of the primary specimen during surgical procedure (e.g., lumpectomy). It includes a probe, a handpiece with an optical component including a digital camera which is inserted into the cavity for image capture, and a cable which includes a connection to the computerised system and a fibre optic light guide. This is a reusable device.

Class C

50

Intravascular/intrac avitary-circulation hyperthermia system

An assembly of devices designed to circulate warmed fluids or autologous blood through the vasculature or cavity of a targeted anatomical area (e.g., peritoneal/pleural cavities, thorax, abdomen, section of a limb) to treat cancer. It is typically computer-controlled and consists of pumps, heat exchanger, valves, detectors/sensors, clamps, monitors, alarms, disposable tubing/filtration set and oxygenator. It heats the blood/fluids to temperatures up to 43 °C to enhance the effect of drugs [e.g., for intraperitoneal hyperthermic chemotherapy (IPHC)] and help destroy cancer cells.

Class C

51

Intravascular/intrac avitary-circulation hyperthermia system set/Kit for hyperthermic perfusion

A collection of sterile devices used with an intravascular/intracavitary-circulation hyperthermia system for the circulation of blood/fluid between the patient and the system’s extracorporeal circuit during cancer therapy. It typically consists of drains/catheters, tubing, connectors, manual clamps, and hard or soft reservoirs; some types may include in-line filters, an oxygenator, and temperature sensors. This is a single-use device.

Class C

52

Microwave ablation system

An assembly of devices consisting of a generator and a probe (and other accessories) intended to generate and transmit microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The generator connects via a delivery cable to a probe for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, natural orifice or open surgery procedures to ablate tissue typically in the liver, lung, pancreas, kidney, and uterus (e.g., endometrial ablation).

Class C

53

Microwave ablation system generator

A mains electricity (AC-powered) device intended to generate microwave energy for localized non- vascular soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia (excludes cerebral and coronary tissues). The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, natural orifice or open surgery procedures to ablate tissue typically in the liver, lung, pancreas, kidney, and uterus (e.g., endometrial ablation).

Class C

54

Microwave ablation system probe/microwave ablation antenna

A hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The device is intended to be used in percutaneous, endoscopic [e.g., gastroscopic, laparoscopic], natural orifice or open surgery procedures to ablate tissues (e.g., endometrial ablation).

Class C

55

Microwave hyperthermia system

A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically.

Class C

56

Microwave hyperthermia system applicator, extracorporeal

A component of a microwave hyperthermia system designed to direct and deliver microwave energy used to produce a systemic or local heating effect. It is typically mounted on a floor, wall, or ceiling suspension that allows the operator to position the microwave source from a point outside the patient’s body. The applicator assembly includes cables and connectors that interface with the energy-generating unit of the hyperthermia system during treatments.

Class C

57

Microwave hyperthermia system applicator, intracorporeal

A component of a microwave hyperthermia system designed to be placed inside the body to deliver microwave energy to produce a systemic or local heating effect. It is also referred to as an interstitial applicator or probe and is typically a catheter- enclosed conductor of microwave energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the device during operation.

Class C

58

Microwave/electros surgical system generator

An electrically-powered component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It is not intended for inert gas electrosurgery.

Class C

59

Multi-modality hyperthermia system

A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using multiple energy sources, for the treatment of malignant or benign tumours, or other disease conditions (excludes cerebral and coronary tissues). It includes a patient- end applicator, software, and a multi-modality generator(s)/control unit. It is intended to achieve whole-body and localized heating of tissues using two or more energy sources [e.g., ultrasound, radio- frequency (RF), microwave, circulating heated fluid] through either externally-mounted components, or from catheter- or probe-type applicators inserted endoscopically or surgically.

Class C

60

Photopheresis system blood set

A collection of devices used as part of a photopheresis system for extracorporeal photoimmune therapy to treat immune disorders, especially cutaneous T-cell lymphoma (CTCL). It typically consists of tubing (patient and fluid lines), fluid/blood component bags, a dedicated centrifuge bowl, a photoactivation chamber, connectors, and clamps. It conducts blood from the patient to the system’s main unit, aids in blood processing, and returns leukocyte-enriched and untreated components of the blood after irradiation. This is a sterile, single-use device.

Class C

61

Photopheresis system lamp assembly

An assembly of ultraviolet A (UVA)-emitting tubular strip lights that is an exchangeable component of a photopheresis system, and used to irradiate blood components during extracorporeal photoimmune therapy to treat immune disorders, especially cutaneous T-cell lymphoma (CTCL).

Class C

62

Polymer-metal oesophageal stent

A non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures and prevent tumour in-growth. It may also be intended to seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other lesions causing oesophageal leakage (e.g., anastomotic). It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.

Class C

63

Radiation therapy digital imager

An automated device that is typically mounted on the gantry of a linear accelerator and intended to produce digital images of x-rayed anatomical landmarks to guide radiation treatment (e.g., tracking/targeting tumours). The device may be a digital imaging panel (e.g., of silicon) on robotic arms; it may also have an x-ray source to generate higher quality images.

Class C

64

Real-time position management respiratory gating system, optical/Respiratory gating system, radiation procedure

An assembly of electronic devices designed to track the respiratory pattern of a patient by means of optical technology to correlate tumour position with the respiratory cycle during radiation treatment planning, radiotherapy, computed tomography (CT) imaging, or other radiation procedures. It provides real-time position management (RPM) and involves optical-based tracking (e.g., video, infrared, laser) of the respiratory cycle to enable irradiation control during the procedure. It may include a tracking camera connected to a dedicated personal computer workstation and a reflective chest wall/abdominal marker.

Class C

65

Scalp cooling system, hair loss

An assembly of electrically-powered devices intended to reduce scalp hair loss associated with intravenous chemotherapy treatment by cooling the scalp to cause vasoconstriction and reduction of chemotherapy drug uptake by the follicular cells. It consists of a control unit which pumps a cooling agent to a head-worn cap containing coolant channels and temperature monitoring sensors. An insulating cap (e.g., neoprene) may be worn over the cooling cap to secure it and prevent condensation.

Class B

66

Stereotactic radiosurgery system for central nervous system (CNS)

A set of devices that are designed to uses very precise beams of gamma rays to treat an area of disease (lesion) or growth (tumor), especially in the brain, upper spine and in certain cases, vascular abnormalities.

Class D

67

Teletherapy radionuclide system table, powered

A device that is a component of a teletherapy radionuclide system (commonly known as a cobalt therapy machine) and that is a powered/programmable table specifically designed to position and support a patient during treatments administered using a therapeutic radionuclide teletherapy system (e.g., a Cobalt-60 teletherapy system). It has electronic and/or software controls for table top height and positioning. It can be a stationary or mobile unit, or incorporated as an integral component of a radionuclide teletherapy system or gantry configuration.

Class B

68

Teletherapy radionuclide system, conventional/Cobal t therapy machine

A stationary assembly of computer-based devices designed to deliver a therapeutic radiation dose to an anatomical region from a single external radiation beam produced by a radionuclide source, typically to treat malignant tumours; it does not provide image- guided radiation therapy (IGRT) functionality during treatment delivery.

Class C

69

Telethermographic system

A telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient’s skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Class A

70

Therapeutic oncological/gynaec ological ultrasound system (High intensity focused ultrasound (HIFU) ablation system)

An assembly of electrically-powered devices designed to treat solid tumours of hard (bone) and/or soft tissue [e.g., liver, kidney, breast, prostate] and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through noninvasive or non-surgically invasive localized application of high intensity focused ultrasound (HIFU) or high intensity therapeutic ultrasound (HITU) intended to gradually denature/ablate tissue lesions. Optimal patient positioning is achieved using an ultrasound scanner or MRI system.

Class C

71

Tumour-therapy radio-frequency hyperthermia system

A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures around 43° Celsius) of the body using radio- frequency (RF) energy, for the treatment of malignant or benign tumours, or other disease conditions; it is not intended for direct tissue ablation. It is intended for both whole-body and localized heating of tissues/organs through either externally- mounted components or from catheter- or probe- type applicators inserted topically, endoscopically, or surgically.

Class C

72

Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal

A component of a radio-frequency (RF) hyperthermia system designed to be placed in the body to deliver radio-frequency (RF) energy to produce a systemic or local heating effect for the treatment of malignant or benign tumours, or other disease conditions. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of RF energy that is introduced into the body either manually or endoscopically. This is a single use device.

Class C

73

Ultrasonic hyperthermia system/Ultrasonic ablation system

An assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43 deg Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disease conditions. Energy delivered to the patient is from either an externally- mounted transducer or a transducer-containing catheter or probe used topically or inserted endoscopically or surgically. It is not intended for physiotherapy applications.

Class C

74

Ultrasound hyperthermia system transducer, extracorporeal

An ultrasound (US) transducer assembly that is a component of an ultrasound hyperthermia system used to induce systemic or local body heating of sufficient magnitude to create a targeted therapeutic effect. It is mounted within the gantry or housing of the hyperthermia system or mounted on a floor, wall, or ceiling suspension that allows the operator to position the transducer assembly external to the patient during treatment.

Class C

75

Ultraviolet Extracorporeal Photopheresis system

An assembly of devices used for extracorporeal photoimmune therapy to treat immune disorders, especially cutaneous T-cell lymphoma (CTCL). It irradiates the leukocyte-rich fraction of peripheral blood by UVA radiation extracorporeally and returns back the treated and untreated blood to the patient. This system may or may not use a UV-active drug (either ingested by patient or injected into the leukocyte-rich fraction of the extracted peripheral blood)

Class C

76

Accupressure wristband

Intended for the application of pressure to the Neikuan (P6) acupressure point on the wrist, the area identified to help relieve the sensation of nausea.

Class A (Self Notified)

77

Antimicrobial postsurgical brassiere

Intended to support and/or contour the breast(s) or hold a dressing in place after surgical intervention (e.g. thoracic surgery, mastectomy, lumpectomy). May be used to prevent the formation of oedema and to support venous return and lymphatic drainage.

Class A (Self Notified)

78

Antimicrobial postsurgical female underpants

It is intended for use during medical treatment (e.g., chemotherapy) or be used to protect the skin following treatment with a medication (e.g. ointment, cream).

Class A (Self Notified)

79

Brachytherapy radionuclide phantom, test object

Intended to mimic the functional/physical characteristics of normal or diseased human organs during performance evaluations of brachytherapy system

Class A (Self Notified)

80

Breast binder

A non-sterile device intended to be applied to the breast or breasts for soft tissue support or securing a dressing in place after surgical procedures.

Class A (Self Notified)

81

Cervical cytology scraper, reusable

Intended to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer.

Class A (Self Notified)

82

Cytotoxic waste receptacle

Intended to safely deposit, collect and store cytotoxic materials (e.g., chemotherapy/antineoplastic drugs).

Class A (Self Notified)

83

FerriScan R2-MRI Analysis System

The FerriScan R2-MRI Analysis System is intended to measure liver iron concentration to aid in the identification and monitoring of non- transfusion dependent thalassemia patients receiving therapy with deferasirox.

Class C

84

Blood photochemical treatment agent

A sterile photochemical agent (psoralen) intended to be used in conjunction with ultraviolet A (UVA) irradiation to eliminate nucleated cells from blood or blood components (e.g. plasma, leukocyte-enriched blood fraction).

Class C