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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.
 
DeviceFONAR NMR WHOLE BODY SCANNER BETA 3000
Generic NameSystem, nuclear magnetic resonance imaging
Regulation Number892.1000
ApplicantFonar Corp.
110 Marcus Dr.
Melville, NY 11747
PMA NumberP830076
Supplement NumberS007
Date Received08/25/1986
Decision Date12/05/1986
Product Code LNH 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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