[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: 21CFR892.1840]

[Page 501]
 
                        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. 892.1840  Radiographic film.

    (a) Identification. Radiographic film is a device that consists of a 
thin sheet of radiotransparent material coated on one or both sides with 
a photographic emulsion intended to record images during diagnostic 
radiologic procedures.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.