[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.1800]

[Page 316]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 872--DENTAL DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 872.1800  Extraoral source x-ray system.

    (a) Identification. An extraoral source x-ray system is an AC-
powered device that produces x-rays and is intended for dental 
radiographic examination and diagnosis of diseases of the teeth, jaw, 
and oral structures. The x-ray source (a tube) is located outside the 
mouth. This generic type of device may include patient and equipment 
supports and component parts.
    (b) Classification. Class II.