[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: 21CFR892.1750]

[Page 521]
 
                        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. 892.1750  Computed tomography x-ray system.

    (a) Identification. A computed tomography x-ray system is a 
diagnostic x-ray system intended to produce cross-sectional images of 
the body by computer reconstruction of x-ray transmission data from the 
same axial plane taken at different angles. This generic type of device 
may include signal analysis and display equipment, patient and equipment 
supports, component parts, and accessories.
    (b) Classification. Class II.