[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: 21CFR892.1640]

[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. 892.1640  Radiographic film marking system.

    (a) Identification. A radiographic film marking system is a device 
intended for medical purposes to add identification and other 
information onto radiographic film by means of exposure to visible 
light.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994]