§892.1910 Radiographic grid.

(a) Identification. A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]

§892.1950 Radiographic

anthropomorphic phantom.

(a) Identification. A radiographic anthropomorphic phantom is a device intended for medical purposes to simulate a human body for positioning radiographic equipment.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807. The device is exempt from the current good manufacturing practice regulations in part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

§ 892.1960 Radiographic intensifying

screen.

(a) Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible

ment protocol (PDP) is required. The effective date of the requirement for premarket approval has not been established. See § 892.3.

[60 FR 36639, July 18, 1995]

§892.2010 Medical image storage device.

(a) Identification. A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

[63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998, as amended at 65 FR 2323, Jan. 14, 2000]

§ 892.2020 Medical image communications device.

(a) Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

[63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998, as amended at 65 FR 2323, Jan. 14, 2000]

§ 892.2030 Medical image digitizer.

(a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

(b) Classification. Class II (special controls; voluntary standards-Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.).

[63 FR 23387, Apr. 29, 1998]

§892.2040 Medical image hardcopy device.

(a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser print

ers.

(b) Classification. Class II (special controls; voluntary standards-Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

[63 FR 23387, Apr. 29, 1998]

§892.2050 Picture archiving and communications system.

(a) Identification. A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

(b) Classification. Class II (special controls; voluntary standards-Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

[63 FR 23387, Apr. 29, 1998]

Subparts C-E [Reserved]

Subpart F-Therapeutic Devices §892.5050 Medical charged-particle radiation therapy system.

(a) Identification. A medical chargedparticle 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. This generic type of device may include signal analysis and display equipment, patient and

equipment supports, treatment planning computer programs, component parts, and accessories.

(b) Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 64 FR 1125, Jan. 8, 1999]

§892.5300 Medical neutron radiation therapy system.

(a) Identification. A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment support, treatment planning computer programs, component parts, and accessories.

(b) Classification. Class II.

§ 892.5650 Manual radionuclide appli cator system.

(a) Identification. A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at FR 2323, Jan. 14, 2000]

§892.5700 Remote controlled radionuclide applicator system.

(a) Identification. 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. This generic type of device may

(a) Identification. A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994]

$892.5750 Radionuclide radiation therapy system.

(a) Identification. 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. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

(b) Classification. Class II. $892.5770 Powered radiation therapy patient support assembly.

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

(b) Classification. Class II.

$892.5780 Light beam patient position indicator.

(a) Identification. A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]

§892.5840 Radiation therapy simulation system.

(a) Identification. 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. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

(b) Classification. Class II. §892.5900 X-ray radiation therapy system.

(a) Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

§892.6500 Personnel protective shield. (a) Identification. A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 65 FR 2323, Jan. 14, 2000]

Subpart A-General Provisions $895.1 Scope.

(a) This part describes the procedures by which the Commissioner may institute proceedings to make a device intended for human use that presents substantial deception or an unreasonable and substantial risk of illness or injury a banned device.

(b) This part applies to any "device", as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (act) that is intended for human use.

(c) A device that is made a banned device in accordance with this part is adulterated under section 501(g) of the act. A restricted device that is banned may also be misbranded under section 502(q) of the act.

(d) Although this part does not cover devices intended for animal use, the manufacturer, distributor, importer, or any other person(s) responsible for the labeling of the device that is banned cannot avoid the ban by relabeling the device for veterinary use. A device that has been banned from human use but that also has a valid veterinary use may be marketed for use as a veterinary device only under the following conditions: The device shall comply with all requirements applicable to veterinary devices under the Federal Food, Drug, and Cosmetic Act and this chapter, and the label for the device shall bear the following statement: "For Veterinary Use Only. Caution: Federal law prohibits the distribution of this device for human use." A device so labeled, however, that is determined by the Food and Drug Administration to be intended for human use, will be considered to be a banned device. In determining whether such a device is intended for human use, the Food and Drug Administration will consider. among other things, the ultimate destination of the device.

$895.20 General.

The Commissioner may initiate a proceeding to make a device a banned device whenever the Commissioner finds, on the basis of all available data and information, that the device presents substantial deception or an unreasonable and substantial risk of illness or injury that the Commissioner