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Electronic Code of Federal Regulations

e-CFR data is current as of November 7, 2019

Title 21Chapter ISubchapter HPart 892Subpart F → §892.5050


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart F—Therapeutic Devices


§892.5050   Medical charged-particle radiation therapy system.

(a) Identification. 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. 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]

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