21 C.F.R. § 892.5750

Current through September 30, 2024
Section 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.

21 C.F.R. §892.5750