Title 21: Food and Drugs
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/ PART 892 - RADIOLOGY DEVICES
/ Subpart F - Therapeutic Devices / § 892.5740 Radionuclide teletherapy source.
§ 892.5740 Radionuclide teletherapy source.
(a) Identification. A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.