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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.
 
DeviceGYREX, MODELS S3500 & S5000
Generic NameSystem, nuclear magnetic resonance imaging
Regulation Number892.1000
ApplicantElscint, Inc.
930 Commonwealth Ave.
Boston, MA 02215
PMA NumberP840007
Supplement NumberS001
Date Received12/31/1986
Decision Date04/02/1987
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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