[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: 21CFR892.1710]

[Page 510]
 
                        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. 892.1710  Mammographic x-ray system.

    (a) Identification. A mammographic x-ray system is a device intended 
to be used to produce radiographs of the breast. This generic type of 
device may include signal analysis and display equipment, patient and 
equipment supports, component parts, and accessories.
    (b) Classification. Class II.