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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.
 
DeviceGYROSCAN(TM)
Generic NameSystem, nuclear magnetic resonance imaging
Regulation Number892.1000
ApplicantPhilips Medical Systems, Inc.
710 Bridgeport Ave.
P.O. Box 860
Shelton, CT 06484
PMA NumberP840063
Supplement NumberS002
Date Received10/31/1986
Decision Date01/30/1987
Product Code LNH 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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