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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameGE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
Classification Namesystem, nuclear magnetic resonance imaging
Generic Namenuclear magnetic resonance imaging system
Regulation Number892.1000
ApplicantGENERAL ELECTRIC CO.
PMA NumberP830074
Supplement NumberS014
Date Received12/18/1987
Decision Date05/05/1988
Product Code
LNH[ Registered Establishments with LNH ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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