GroundRules
21 CFR 892.5300: Medical neutron radiation therapy system.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 892—RADIOLOGY DEVICES
- Subpart F—Therapeutic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON