[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR892.1100]

[Page 506]
 
                        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. 892.1100  Scintillation (gamma) camera.

    (a) Identification. A scintillation (gamma) camera is a device 
intended to image the distribution of radionuclides in the body by means 
of a photon radiation detector. This generic type of device may include 
signal analysis and display equipment, patient and equipment supports, 
radionuclide anatomical markers, component parts, and accessories.
    (b) Classification. Class I (general controls).

[55 FR 48443, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]