[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: 21CFR892.1700]

[Page 510]
 
                        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. 892.1700  Diagnostic x-ray high voltage generator.

    (a) Identification. A diagnostic x-ray high voltage generator is a 
device that is intended to supply and control the electrical energy 
applied to a diagnostic x-ray tube for medical purposes. This generic 
type of device may include a converter that changes alternating current 
to direct current, filament transformers for the x-ray tube, high 
voltage switches, electrical protective devices, or other appropriate 
elements.
    (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 61 FR 1125, Jan. 16, 1996; 66 
FR 38819, July 25, 2001]