[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR892.1760]

[Page 500]
 
                        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. 892.1760  Diagnostic x-ray tube housing assembly.

    (a) Identification. A diagnostic x-ray tube housing assembly is an 
x-ray generating tube encased in a radiation-shielded housing that is 
intended for diagnostic purposes. This generic type of device may 
include high voltage and filament transformers or other appropriate 
components.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]

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