[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: 21CFR892.1650]

[Page 519-520]
 
                        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. When intended as an accessory to the 
device

[[Page 520]]

described in paragraph (a) of this section, the fluoroscopic compression 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001]