[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR892.1650]

[Page 499]
 
                        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. 892.1650  Image-intensified fluoroscopic x-ray system.

    (a) Identification. An image-intensified fluoroscopic x-ray system 
is a device intended to visualize anatomical structures by converting a 
pattern of x-radiation into a visible image through electronic 
amplification. This generic type of device may include signal analysis 
and display equipment, patient and equipment supports, component parts, 
and accessories.
    (b) Classification. Class II.