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Title 21 Part 892 → Subpart F → §892.5750

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart F → §892.5750

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart F → §892.5750

e-CFR data is current as of July 12, 2019

Title 21Chapter ISubchapter HPart 892Subpart F → §892.5750


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart F—Therapeutic Devices


§892.5750   Radionuclide radiation therapy system.

(a) Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

(b) Classification. Class II.