[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR892.1390]

[Page 518]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 892--RADIOLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 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.