[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: 21CFR892.1170]

[Page 516]
 
                        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. 892.1170  Bone densitometer.

    (a) Identification. A bone densitometer is a device intended for 
medical purposes to measure bone density and mineral content by x-ray or 
gamma ray transmission measurements through the bone and adjacent 
tissues. This generic type of device may include signal analysis and 
display equipment, patient and equipment supports, component parts, and 
accessories.
    (b) Classification. Class II.