[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: 21CFR892.1600]

[Page 519]
 
                        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. 892.1600  Angiographic x-ray system.

    (a) Identification. An angiographic x-ray system is a device 
intended for radiologic visualization of the heart, blood vessels, or 
lymphatic system during or after injection of a contrast medium. This 
generic type of device may include signal analysis and display 
equipment, patient and equipment supports, component parts, and 
accessories.
    (b) Classification. Class II.