Code of Federal Regulations (Last Updated: July 5, 2024) |
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 |
§ 892.5750 - Radionuclide radiation therapy system.
Latest version.
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§ 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.