21 CFR 892.1390 — System, Rebreathing, Radionuclide

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1390

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
IYTSystem, Rebreathing, Radionuclide2483rd Party
Innolitics

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