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

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.