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§ 892.1390 Radionuclide rebreathing system.

21 CFR 892.1390

Citation21 CFR 892.1390
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 892.1390 Radionuclide rebreathing system.

(a) Identification. A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere). This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.