21 CFR § 892.1390 - Radionuclide rebreathing system.

---
identifier: "/us/cfr/t21/s892.1390"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1390 - Radionuclide rebreathing system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1390"
section_name: "Radionuclide rebreathing system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "892"
part_name: "RADIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 1567, Jan. 20, 1988, unless otherwise noted."
cfr_part: "892"
---


# 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.