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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameGYREX, MODELS S3500 & S5000
Classification Namesystem, nuclear magnetic resonance imaging
Generic Namenuclear magnetic resonance imaging system
Regulation Number892.1000
ApplicantELSCINT, INC.
PMA NumberP840007
Supplement NumberS001
Date Received12/31/1986
Decision Date04/02/1987
Product Code
LNH[ Registered Establishments with LNH ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No