[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: 21CFR892.1110]

[Page 516]
 
                        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. 892.1110  Positron camera.

    (a) Identification. A positron camera is a device intended to image 
the distribution of positron-emitting radionuclides in the body. 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 48444, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]