[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: 21CFR892.1330]

[Page 537]
 
                        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. 892.1330  Nuclear whole body scanner.

    (a) Identification. A nuclear whole body scanner is a device 
intended to measure and image the distribution of radionuclides in the 
body by means of a wide-aperture detector whose position moves in one 
direction with respect to the patient. This generic type of device may 
include signal analysis and display equipment, patient and equipment 
supports, radionuclide anatomical markers, component parts, and 
accessories.
    (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 Sec. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000]