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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
Generic NameSystem, nuclear magnetic resonance imaging
Regulation Number892.1000
ApplicantGeneral Electric Co.
P0 Box 414
Milwaukee, WI 
PMA NumberP830074
Supplement NumberS010
Date Received12/23/1986
Decision Date03/30/1987
Product Code LNH 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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