[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR892.1300]

[Page 516-517]
 
                        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.

[[Page 517]]

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]