Title 21: Food and Drugs
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/ PART 892 - RADIOLOGY DEVICES
/ Subpart F - Therapeutic Devices / § 892.5750 Radionuclide radiation therapy system.
§ 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.