21 C.F.R. § 892.5300 Medical neutron radiation therapy system.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 892.5300 Medical neutron radiation therapy system.
