21 CFR § 892.5050 - Medical charged-particle radiation therapy system.

---
identifier: "/us/cfr/t21/s892.5050"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.5050 - Medical charged-particle radiation therapy system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.5050"
section_name: "Medical charged-particle radiation therapy system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "892"
part_name: "RADIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 1567, Jan. 20, 1988, unless otherwise noted."
cfr_part: "892"
---


# 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]