[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: 21CFR892.1310]

[Page 517]
 
                        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. 892.1310  Nuclear tomography system.

    (a) Identification. A nuclear tomography system is a device intended 
to detect nuclear radiation in the body and produce images of a specific 
cross-sectional plane of the body by blurring or eliminating detail from 
other planes. This generic type of devices may include signal analysis 
and display equipment, patient and equipment supports, radionuclide 
anatomical markers, component parts, and accessories.
    (b) Classification. Class II.