U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

Searching within: All TitlesTitle 21Chapter IPart 892Subpart F - Subpart F—Therapeutic Devices
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§ 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.