[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: 21CFR892.1000]

[Page 506]
 
                        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. 892.1000  Magnetic resonance diagnostic device.


    (a) Identification. A magnetic resonance diagnostic device is 
intended for general diagnostic use to present images which reflect the 
spatial distribution and/or magnetic resonance spectra which reflect 
frequency and distribution of nuclei exhibiting nuclear magnetic 
resonance. Other physical parameters derived from the images and/or 
spectra may also be produced. The device includes hydrogen-1 (proton) 
imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 
spectroscopy, and chemical shift imaging (preserving simultaneous 
frequency and spatial information).
    (b) Classification. Class II.

[53 FR 5078, Feb. 1, 1989]