21 CFR § 892.5300 - Medical neutron radiation therapy system.

---
identifier: "/us/cfr/t21/s892.5300"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.5300 - Medical neutron radiation therapy system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.5300"
section_name: "Medical neutron 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"
---


# 892.5300 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.