[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: 21CFR892.1420]

[Page 498]
 
                        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. 892.1420  Radionuclide test pattern phantom.

    (a) Identification. A radionuclide test pattern phantom is a device 
that consists of an arrangement of radiopaque or radioactive material 
sealed in a solid pattern intended to serve as a test for a performance 
characteristic of a nuclear medicine imaging device.
    (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]