[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: 21CFR892.1630]

[Page 539]
 
                        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. 892.1630  Electrostatic x-ray imaging system.

    (a) Identification. An electrostatic x-ray imaging system is a 
device intended for medical purposes that uses an electrostatic field 
across a semiconductive plate, a gas-filled chamber, or other similar 
device to convert a pattern of x-radiation into an electrostatic image 
and, subsequently, into a visible image. This generic type of device may 
include signal analysis and display equipment, patient and equipment 
supports, component parts, and accessories.
    (b) Classification. Class II.