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21 CFR 892.5750

§ 892.5750 Radionuclide radiation therapy system.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 892.5750, § 892.5750 Radionuclide radiation therapy system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91340
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(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.