[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: 21CFR892.1370]

[Page 497]
 
                        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. 892.1370  Nuclear anthropomorphic phantom.

    (a) Identification. A nuclear anthropomorphic phantom is a human 
tissue facsimile that contains a radioactive source or a cavity in which 
a radioactive sample can be inserted. It is intended to calibrate 
nuclear uptake probes or other medical instruments.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989]