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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 NumberS017
Date Received07/18/1988
Decision Date07/29/1988
Product Code LNH 
Advisory Committee Radiology
Supplement Type 30-Day Supplement
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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