CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 892—RADIOLOGY DEVICES > SUBPART F—Therapeutic Devices (§892.5050 to §892.5930) > 892.5900—X-ray radiation therapy system.

892.5900—X-ray radiation therapy system.

(a) Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
(b) Classification. Class II.