[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR892.1300]

[Page 507]
 
                        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. 892.1300  Nuclear rectilinear scanner.

    (a) Identification. A nuclear rectilinear scanner is a device 
intended to image the distribution of radionuclides in the body by means 
of a detector (or detectors) whose position moves in two directions 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 the limitations in Sec. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000; 66 
FR 38818, July 25, 2001]