21 CFR 892.1370
§ 892.1370 Nuclear anthropomorphic phantom.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 892.1370, § 892.1370 Nuclear anthropomorphic phantom, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91273
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Full text
(a) Identification. A nuclear anthropomorphic phantom is a human tissue facsimile that contains a radioactive source or a cavity in which a radioactive sample can be inserted. It is intended to calibrate nuclear uptake probes or other medical instruments.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.