[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR892.1380]

[Page 538]
 
                        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. 892.1380  Nuclear flood source phantom.

    (a) Identification. A nuclear flood source phantom is a device that 
consists of a radiolucent container filled with a uniformly distributed 
solution of a desired radionuclide. It is intended to calibrate a 
medical gamma camera-collimator system for uniformity of response.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 
FR 38819, July 25, 2001]