N°

Nom du dispositif

Utilisation prévue

Classe de risque

1

Absorbable perirectal spacer

An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum.

Classe C

2

Absorbable tissue spacer for radiotherapy

An absorbable material used to reduce radiation exposure of normal tissue during radiotherapy by implanting surgically or percutaneously between tissue, internal organs, etc., to make a space between the malignant tumor and normal tissue.

Classe D

3

Applicator for bile duct manual brachytherapy

A manual brachytherapy applicator specifically designed for bile duct radiation therapy. An applicator designed to have a configuration that facilitates manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the bile duct.

Classe C

4

Applicator for bladder manual brachytherapy

A manual brachytherapy applicator designed to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the bladder.

Classe C

5

Applicator for bladder remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically

designed for bladder radiation therapy. It is designed to be temporarily implanted in the bladder. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites.

Classe C

6

Applicator for brachytherapy non- central circulatory general-purpose manual

A general-purpose brachytherapy applicator used to facilitate radiotherapy. A single or module applicator designed to facilitate manual placement (puncture, local placement, placement under endoscopy, and placement and removal using an image diagnostic system) of single or multiple therapeutic radiation sources in treatment sites in the non-central circulatory system.

Classe C

7

Applicator for brachytherapy non- central circulatory general-purpose remote after loading

A general-purpose remote controlled brachytherapy applicator used to facilitate radiotherapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer- controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites in the non-central circulatory system.

Classe C

8

Applicator for bronchial manual brachytherapy applicator

A manual brachytherapy applicator specifically designed for temporarily use in bronchial radiation therapy. A single or module applicator designed to facilitate manual placement (placement using an endoscope or positioning, placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites. It may be designed to be standard in configuration or to handle specific radiation sources.

Classe C

9

Applicator for bronchial remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically

designed for bronchial radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources in the bronchus.

This device group includes various applicators such as hollow needles, tubes, and catheters, as well as associated devices and connectors.

Classe C

10

Applicator for esophagus manual brachytherapy

A manual brachytherapy applicator specifically designed for esophagus radiation therapy. A single or module applicator designed to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the esophagus. It may be designed to be standard in configuration or to handle specific radiation sources.

Classe C

11

Applicator for esophagus remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically designed for esophagus radiation therapy. It is designed to be temporarily implanted in the esophagus. It serves as a guide for computer-controlled temporary placement and removal of a single or

multiple therapeutic radiation sources. This device group includes various applicators such as hollow needles, tubes, and catheters, as well as associated devices and connectors.

Classe C

12

Applicator for eye manual brachytherapy

A template with a groove on the one side. The groove shows the position of the brachytherapy source that is manually, temporarily delivered to the eye surface. The other side is shielded.

Classe C

13

Applicator for nasopharynx manual brachytherapy

A manual brachytherapy applicator specifically designed for nasopharyngeal radiation therapy. A single or module applicator

designed to facilitate manual placement (puncture, endoscopic placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the nasopharynx.

Classe C

14

Applicator for nasopharynx remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically designed for nasopharyngeal radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer- controlled temporary placement and removal of a single or multiple therapeutic radiation sources in the nasopharynx.

Classe C

15

Applicator for neck manual brachytherapy

A manual brachytherapy applicator specifically designed for neck radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, local placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the neck tissues.

Classe C

16

Applicator for neck remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically

designed for neck radiation therapy. It is designed to be temporarily implanted in the neck tissues. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources.

Classe C

17

Applicator for pancreas manual brachytherapy

A manual brachytherapy applicator specifically designed for pancreatic radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, endoscopic placement, or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the pancreas. It may be designed to be standard in configuration or to handle specific radiation sources.

Classe C

18

Applicator for pancreas remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically designed for pancreatic radiation therapy. It is designed to be temporarily

implanted in the pancreas. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple

therapeutic radiation sources at treatment sites.

Classe C

19

Applicator for prostate manual brachytherapy

A manual brachytherapy applicator specifically designed for prostate radiation therapy. A single or module applicator designed to facilitate manual placement (puncture or placement or removal with a trigger loading device, an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the prostate gland. It may be designed to be standard in configuration or to handle specific radiation sources.

Classe C

20

Applicator for prostate remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically designed for prostate radiation therapy. It is designed to be temporarily implanted in the prostate gland. It serves as a guide for computer- controlled temporary placement and removal of a single or multiple therapeutic radiation sources.

Classe C

21

Applicator for rectal/anal remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically designed for rectal or anal radiation therapy. It is designed to be temporarily implanted in the rectum or anus. It serves as a guide for computer- controlled temporary placement and removal of a single or multiple therapeutic radiation sources.

Classe C

22

Applicator for tongue manual brachytherapy

A manual brachytherapy applicator specifically designed for lingual radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, local placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the tongue and the surrounding tissues. It may be designed to be standard in configuration or to handle specific radiation sources.

Classe C

23

Applicator for tongue remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically designed for tongue or oral cavity radiation therapy. It is designed to be temporarily implanted in the tongue or the surrounding tissues. It serves as a guide for computer-controlled

temporary placement and removal of a single or multiple therapeutic radiation sources.

Classe C

24

Applicator for vaginal manual brachytherapy

A manual brachytherapy applicator specifically designed for vaginal or transvaginal radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, local placement,

endoscopic placement or placement and removal using a diagnostic

imaging system) of single or multiple therapeutic radiation sources in treatment sites.

Classe C

25

Applicator for vaginal remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically designed for vaginal or transvaginal radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer- controlled temporary placement and removal of a single or multiple therapeutic radiation sources in the vagina.

Classe C

26

Blood vessel manual brachytherapy applicator

A manual brachytherapy applicator designed exclusively for blood vessel radiotherapy. Most commonly, it is used to prevent formation of plaque, stenosis and restenosis in blood vessels after surgery. A single or module device designed to facilitate manual placement (placement and removal under endoscopy or using an image diagnostic system) of single or multiple therapeutic radiation sources in the treatment site.

Classe D

27

Blood vessel remote after loading brachytherapy applicator

A remote controlled brachytherapy applicator designed exclusively for radiotherapy in blood vessels. This treatment is used to prevent plaque formation. and stenosis in blood vessels after surgery. It is designed for temporary implantation in a blood vessel, and serves as a guide for computer- controlled temporary placement and removal of single or multiple therapeutic radiation sources at treatment sites.

Classe D

28

Brachytherapy needle

A sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy).

Classe B

29

Brachytherapy radionuclide phantom, anthropomorphic

A device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue- equivalent model designed to simulate the functional, physical, or a combination of these characteristics of normal or diseased human organs.

Classe B

30

Brachytherapy system chair

A mains electricity (AC-powered) device (a chair or stool) that is a component of a brachytherapy system and which is specifically designed to support and position a patient during brachytherapy radiation treatments given by either a manual applicator or a

remote after loading brachytherapy system applicator.

Classe B

31

Brachytherapy system remote after loading source safe

A component of a remote after loading brachytherapy system consisting of a shielded vault, and associated source retraction and extrusion mechanisms, alarms, and related mechanical, electronic and software controls, used to shield the brachytherapy sources in order to protect system operators, brachytherapy patients and others from the continuous emissions of the radioactive brachytherapy source(s) when they are not in use.

Classe C

32

Brachytherapy system remote after loading source transfer tube

The transfer tube, when attached to the applicator and the after loading system, provides a continuous closed passage that allows for moving either a radioactive source(s) and/or positioning markers from the shielded source storage compartment of the remote after loading brachytherapy system into appropriate positions within a brachytherapy applicator that has been positioned at a location either on the surface of, or within, the patient.

Classe C

33

Brain manual brachytherapy applicator

An applicator specifically designed for brain radiotherapy. A single or module applicator designed to facilitate manual placement (puncture, placement under endoscopy, or placement and removal using an image diagnostic system) of single or

multiple therapeutic radiation sources in the brain.

Classe D

34

Brain remote after loading brachytherapy applicator

A remote controlled brachytherapy applicator designed exclusively for brain radiotherapy for temporary implantation in the body. It serves as a computer- controlled guide for temporary placement and removal

of a single or multiple therapeutic radiation sources in the brain.

Classe D

35

Breast ductography cannula

A thin, sterile, semi-rigid or rigid metal tube that is inserted into the nipple of the female breast to inject a contrast medium into the lactiferous ducts to enhance their visualization during a radiographic procedure.

Classe C

36

Central circulatory general-purpose manual brachytherapy applicator

A single or module applicator designed to facilitate manual placement (puncture, local placement, placement under endoscopy or placement and removal using an image diagnostic system) of single or multiple therapeutic radiation sources in treatment sites in the central circulatory system.

Classe D

37

Central circulatory general-purpose remote after loading brachytherapy applicator

Intended to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites in the central circulatory system.

Classe D

38

Central circulatory manual brachytherapy therapeutic radionuclide system

A device that places a radiation source manually or automatically at the treatment site in the central circulatory system for providing a required radiation dose during radiotherapy. This device does not equip a

remotely controlled radiation source transporter.

Classe D

39

Central circulatory permanent implant manual brachytherapy therapeutic radionuclide source

A device for the central circulatory system to be placed permanently in the body for radiotherapy which is necessary for treatment and symptomatic therapy, and uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear reactor. The radiation source, which is permanently placed manually, is designed to achieve compatibility with tissues. The radiation source can be selected from the following forms – e.g., microsphere, globe, stent, seed, and wire- in order to generate low- energy photons, beta particles, or alpha particles.

Classe D

40

Central circulatory remote after loading brachytherapy therapeutic radionuclide source

A device for the central circulatory system used as radiation source to deliver a high or low dose rate with an after-loading brachytherapy device designed for radiotherapy which is necessary for treatment and symptomatic therapy, and uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear reactor.

Classe D

41

Central circulatory remote after loading brachytherapy therapeutic radionuclide system

A device that places a radiation source temporarily at the treatment site in the central circulatory system for providing a required radiation dose during radiotherapy. This device equips a remotely controlled radiation source transporter.

Classe D

42

Central circulatory temporary placement manual brachytherapy therapeutic radionuclide source

A device for the central circulatory system that uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear reactor, and is placed in the body temporarily, and removed after the pre-determined treatment period. The radiation source, which is temporarily inserted manually, is supplied in various forms

– e.g., encapsulated, sealed, plated, foiled, or embedded.

Classe D

43

Compact thermoluminescent dosimetry electrometer

Thermoluminescence dosimeter (TLD) is used to measure the radiation dose emitted to the phantom, eyes and other organs with high radio sensitivity.

Classe A

44

Conformal Brachytherapy Source

The intended use of the device is for the treatment of cancer by temporary intraoperative or surface irradiation. The device contains radioactive material with activity up to 200 mci and is indicated for treatment of temporary intraoperative, interstitial, intracavitary or surface application to treat selected localized tumors.

Classe C

45

High-frequency hyperthermia system

A system used to generate high- temperatures and to control the provision of heat to the body in the treatment of malignant and benign tumors, or other diseases.

Classe C

46

Intra-vaginal organ positioning device for diagnostic imaging and radiotherapy

A device that is specifically designed to be inserted in the vagina to properly position and fix the surrounding organs such as uterine cervix, rectum, and urinary bladder for image diagnosis or radiotherapy. This device is used to facilitate reproducible positioning for continuous image examination or continuous radiotherapy.

Classe B

47

Laser irradiation therapy kit

A kit includes a puncture needle, a guide wire, and a guiding sheath for guiding probes (used for laser irradiation therapy, for example).

Not all of the components are included; in some products, two or more of components are integrated into one.

Classe B

48

Living tissue radiotherapy system

A low energy X-ray therapy system designed to treat adjacent tumor lesions with high dose X-rays by placing soft X-ray beams from 5 to 50 kV inside the tumor tissue. It is used in both intraoperative radiation and stereotactic localized radiation therapy.

Classe C

49

Medical charged- particle radiation therapy system

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy.

Classe C

50

Medical neutron radiation therapy system

A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy

Classe C

51

MOSFET radiation therapy dosimetry system

An assembly of devices using metal oxide semiconductor field- effect transistor (MOSFET) technology intended to be used for on- the-spot patient or anthropomorphic radiation dose verification and monitoring during radiation therapy and radiology procedures.

Applications typically include radiation oncology therapy and dosimetry, treatment plan verification for in vivo dosimetry, brachytherapy, intraoperative radiation therapy, image- guided radiation therapy, and research.

Classe B

52

Non-central circulatory manual brachytherapy therapeutic radionuclide system

A device that places a radiation source manually or automatically at the treatment site in the non-central circulatory system for providing a required radiation dose during radiotherapy.

Classe C

53

Non-central circulatory permanent implant manual brachytherapy therapeutic radionuclide source

A non-central cardiovascular device which is histocompactible and containing an isotope naturally occurring or produced by an accelerator or a nuclear reactor, intended to be permanently implanted in the body for radiation therapy requiring treatment or symptomatic treatment.

Classe C

54

Non-central circulatory remote after loading brachytherapy therapeutic radionuclide source

A device for the non-central circulatory system used as radiation source to deliver a high or low dose rate with an after-loading brachytherapy device designed for radiotherapy which is necessary for treatment and symptomatic therapy, and uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear

reactor.

Classe C

55

Non-central circulatory remote after loading brachytherapy therapeutic radionuclide system

A device that places a radiation source temporarily at the treatment site in the non-central circulatory system for providing a required radiation dose during radiotherapy. This device equips a remotely controlled radiation

source transporter.

Classe C

56

Non-central circulatory temporary placement manual brachytherapy therapeutic radionuclide source

A non-central cardiovascular device containing an isotope naturally occurring or produced by an accelerator or a nuclear reactor, intended to be temporarily implanted in the body and to be removed after a prescribed duration of treatment. Used in brachytherapy, the device is placed and removed

manually or under endoscopic observation.

Classe C

57

Patient positioning device for breast diagnostic imaging and radiotherapy

A device that is specifically designed to properly position and fix a female patient’s breasts and chest for image diagnosis, image-guided surgery, interventional therapy, or radiotherapy.

Classe B

58

Patient positioning device for extremity diagnostic imaging and radiotherapy

A device that is specifically designed to properly position and fix a patient’s arms and legs for image diagnosis, image- guided surgery, interventional therapy, or radiotherapy.

Classe B

59

Patient positioning device for pelvis diagnostic imaging and radiotherapy

The device that consists of frames, plates, or other parts, and is specifically designed to properly position and fix the patient’s abdomen and pelvic region for image diagnosis, image-guided surgery, interventional therapy,

or radiotherapy.

Classe B

60

Patient positioning device for whole body diagnostic imaging and radiotherapy

A device that consists of fixed or adjustable parts (e.g., frames and plates), and is specifically designed to properly position and fix the patient’s whole body for image diagnosis,

image-guided surgery, interventional therapy, or radiotherapy.

Classe B

61

Patient Positioning System, Ultrasound

An assembly of devices used to locate, with ultrasound, internal soft-tissue anatomy that moves relative to external or bony landmarks, to enable subsequent adjustment of the patient for precise external beam radiation treatment of the target tissue. It typically includes an ultrasound imaging system, computerized workstation(s), optical tracking devices, and dedicated software.

Classe C

62

Post Breast Biopsy Hemostatic Breast Compression Device

Intended to achieve and maintain hemostasis of a breast biopsy wound site.

Classe C

63

Powered neutron therapy table

A programmable bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for treatment that uses neutron rays that are generated from the nuclear reactor, etc.

Classe B

64

Powered patient table for accelerator

A bed operates by programmable for electric radiotherapy designed to adjust the patient’s posture and immobilize the patient for radiotherapy that uses medical linear accelerator or non-linear accelerator.

Classe B

65

Powered radiation therapy patient support assembly

A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy

Classe C

66

Powered radionuclide brachytherapy table

A programmable bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for treatment that uses an after loading short-distance irradiation treatment apparatus that is operated manually or electrically.

Classe B

67

Powered remote irradiation therapy table

A programmable electrically operated bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for treatment that uses a remote cobalt

60 radiotherapy apparatus and other remote radionuclide radiotherapy apparatuses.

Classe B

68

Powered X-rays radiation therapy table

A programmable electrically operated bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for treatment that uses an X-ray therapy apparatus.

Classe B

69

Radiation therapy beam-shaping block

A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source

Classe C

70

Radiation therapy simulation system

A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced.

Classe C

71

Radionuclide brachytherapy source

A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy

Classe C

72

Radionuclide dynamic function testing equipment

A device used to measure and record temporal variations of radioisotope concentrations in the body. Specialized devices, such as devices for thyroid uptake measurement, renograms, and radioisotope blood volume measurement, are included.

Classe B

73

Radionuclide radiation therapy system

A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient’s body.

Classe C

74

Radionuclide source for remote irradiation therapy

Radiation sources generated in a reactor and used as in a remote after loading system designed to deliver a therapeutic radiation beam to a target anatomical area. The radiation sources incorporated as a component of the remote after loading system are generally sealed.

Classe C

75

Radionuclide system contour detector for remote irradiation therapy

Intended to precisely determine the outline of the area of the body to be irradiated. Usually, the information obtained from this device is entered into a radiotherapy planning system and utilized for the radiotherapy plan.

Classe C

76

Real-time position management respiratory gating system, optical

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.

Classe C

77

Rectal balloon for prostate immobilization

A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy.

Classe C

78

Remote controlled radionuclide applicator system

A remote controlled radionuclide applicator system is an electromechanical or pneumatic

device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy.

Classe C

79

Stereotactic radiotherapy accelerator system

A stereotactic radiation therapy system for treatment based on a linear accelerator (or microtron). The device may be used to inactivate lymphocytes.

Classe C

80

X-ray CT system for radiotherapy planning

A X-ray CT system that has a special configuration, containing hardware, software, etc. used in radiotherapy planning. It is used to determine the size and positioning of the therapeutic radiation field based on a series of treatment parameters to be generated.

Classe C

81

X-ray radiation therapy system

An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy.

Classe C

82

X-ray/CT combined linear accelerator system

A combined system of a linear accelerator system and an X-ray CT system for radiotherapy planning.

Classe C

83

X-ray/CT combined particle radiotherapy equipment

A combined system of particle radiotherapy equipment and an X-ray CT system for radiotherapy planning.

Classe C

84

X-ray/MR combined linear accelerator system

A system intended to provide treatment planning, image- guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment in indicated. The system operates on the principle of linear acceleration of electrons, providing a predictable radiation field in a beam of well-defined dimensions.

Classe C

85

Applicator for bile duct remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically designed for bile duct radiation therapy. It is designed to be temporarily implanted in the bile duct. It serves as a guide for computer- controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites.

Classe C

86

Applicator for cervical/endometrial manual brachytherapy

A manual brachytherapy applicator specifically designed for uterine cervix or intrauterine radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, placement with an endoscope or a diagnostic imaging system) of single or multiple

therapeutic radiation sources in treatment sites.

Classe C

87

Applicator for Cervical/endometrial remote after loading brachytherapy

A remote-controlled brachytherapy applicator specifically designed for uterine, cervical, or intrauterine radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources in the uterus, cervix and endometrium.

Classe C

88

Applicator for rectal/anal manual brachytherapy

A manual brachytherapy applicator specifically designed for rectal and/or anal radiation therapy. A single or module applicator designed to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the rectum and/or anus.

Classe C

89

Applicator for eye remote after loading brachytherapy

A remote controlled brachytherapy applicator specifically designed for eye radiation therapy. It serves as a guide for computer- controlled temporary placement and removal of a single or multiple therapeutic radiation sources. This device group includes various applicators such as hollow needles, tubes, and catheters, as well as associated devices and connectors.

Classe C

90

Breast brachytherapy system applicator, manual

A manual brachytherapy applicator specifically designed for use in radiation therapy treatments of the breast.

Classe C

91

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.

Classe C

92

Coronary artery brachytherapy system applicator, manual

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

Classe D

93

Coronary artery brachytherapy system applicator, remote 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 remote-controlled afterloading brachytherapy system

Classe D

94

Fluoroscopy/angiography table, powered

A powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).

Classe B

95

Gamma knife for radiotherapy/surgery

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.

Classe D

96

General-purpose brachytherapy system applicator, manual

A general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site.

Classe C

97

General-purpose brachytherapy system applicator, remote- afterloading

A general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area.

Classe C

98

Interventional radiology percutaneous-access kit

A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals.

Classe C

99

Manual brachytherapy source, permanent implant

A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.

Classe D

100

Manual brachytherapy source, temporary placement

A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope in a form that is intended for temporary placement in the body and removal after a specified treatment time. It is used in brachytherapy applications that require direct manual or endoscopically-guided placement and removal. Manually inserted sources intended for temporary placement come in a variety of forms, e.g., encapsulated, sealed, plated, foil or embedded sources.

Classe C

101

Manual brachytherapy system

An assembly of therapeutic, independent devices, manually brought together and intended to deliver a palliative or therapeutic radiation dose to an anatomical region from radionuclide sources. Medical personnel manually place multiple radioactive sources in appliances and applicators for either permanent or temporary delivery at the topical, interstitial, intraluminal, or intracavitary brachytherapy treatment site.

Classe C

102

Manual-afterloading brachytherapy system source delivery procedure kit

A collection of sterile devices intended to dispense/collect hydraulic fluid used to deliver the radiation source train of a manual-afterloading brachytherapy system source transfer device to/from the delivery catheter/applicator. It consists of disposable devices such as syringes, fluid collection bags, adaptors/connectors.

Classe B

103

Manual-afterloading brachytherapy system storage container

A non-sterile radiation-shielding plastic box intended to store a manual- afterloading brachytherapy system. It is typically temporarily used as a safety container to prevent radiation leakage in the event of procedural difficulties.

Classe C

104

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.

Classe C

105

Radiological image marker, implantable

A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x- ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Classe C

106

Remote-afterloading brachytherapy source

A device that is a naturally-occurring, accelerator or reactor produced- radioactive isotope used as a source of radiation in high or low dose rate remote afterloading brachytherapy systems designed to deliver curative or palliative radiotherapy treatments. Sources used in remote afterloading radiotherapy systems may come in a variety of strengths and physical forms, e.g., single encapsulated source (sealed source), ribbons, plated, foil or embedded sources or contained radioactive liquids or gels.

Classe C

107

Remote-afterloading brachytherapy system

An assembly of devices using a remotely-controlled radioactive source transport system designed to deliver a therapeutic or palliative radiation dose

from a single source or source train to an anatomical region by placing the radioactive source(s) temporarily on or in the treatment site.

Classe C

108

Stereotactic radiosurgical system

An assembly of devices designed to deliver a therapeutic radiation dose to an anatomical region from external beams produced from multiple radionuclide sources arranged in a fixed focal point collimated array; typically used to treat brain, neck, breast and spinal tumours. It typically consists of: 1) a stereotactic positioning device attached to the patient to define the three-dimensional (3-D) co- ordinates of the treatment site; 2) fixed diameter collimators; 3) high-density beam blockers; 4) a shielded housing to hold the sources, reducing room radiation; 5) a precision aligned array to cause the source beams to intersect at a single point; and 6) a moveable patient table.

Classe C

109

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.

Classe B

110

Teletherapy radionuclide system, conventional/Cobalt 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.

Classe C

111

Therapeutic x-ray high voltage generator

It is a device that is intended to supply and control the voltage and electrical energy to provide a therapeutic x-ray system (e.g., brachytherapy) with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA).

Classe B

112

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).

Classe C

113

Ultraviolet 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.

Classe C

114

Ultraviolet 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).

Classe C

115

Light beam patient position indicator

Intended to project a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam.

Classe A (non stérile et non mesurant)

116

Manual radionuclide applicator system

Intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy

Classe A (non stérile et non mesurant)

117

Non-powered accelerator system table

Intended to adjust the patient's posture and immobilize the patient for radiotherapy.

Classe A (non stérile et non mesurant)

118

Non-powered neutron therapy table

Intended to adjust the patient's posture and immobilize the patient for treatment that uses neutron rays.

Classe A (non stérile et non mesurant)

119

Non-powered remote irradiation therapy table

Intended to adjust the patient's posture and immobilize the patient for treatment that uses a remote radionuclide radiotherapy apparatus.

Classe A (non stérile et non mesurant)

120

Non-powered X-rays radiation therapy table

Intended to adjust the patient's posture and immobilize the patient for treatment using X-ray radiation therapy

Classe A (non stérile et non mesurant)

121

Operator radiation protection spectacles

Intended to protect the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment.

Classe A (non stérile et non mesurant)

122

Radiation protection gloves

Intended for complete protection of the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures.

Classe A (non stérile et non mesurant)

123

Bile duct brachytherapy system applicator, remote-after loading

A remote after loading brachytherapy applicator specifically designed for use in radiation therapy treatments of the bile duct. It is designed for temporary insertion into the bile duct and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources.

C

124

Bladder brachytherapy system applicator, manual

A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the bladder.

C

125

Brain brachytherapy system applicator, remote-after loading

A remote after loading brachytherapy applicator specifically designed for use in radiation therapy treatments of the brain. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the brain.

C

126

Radionuclide brachytherapy table

A programmable bed for electric radiotherapy to adjust the patient's posture and immobilize the patient for treatment that uses an after loading short-distance

irradiation treatment apparatus that is operated manually or electrically.

B

127

Stationary radiation protection barrier

A device for permanent installation that forms a structural barrier that shields or attenuates radiation emitted from primary radiation source or scattered radiation source.

B