21 CFR 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.

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United States Code