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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameACUTSCAN MODEL 100 MRI SYSTEM
Classification Namesystem, nuclear magnetic resonance imaging
Generic Namenuclear magnetic resonance imaging system
Regulation Number892.1000
ApplicantPALOMEX INSTRUMENTARIUM CORP.
PMA NumberP860010
Supplement NumberS001
Date Received03/09/1987
Decision Date04/22/1987
Product Code
LNH[ Registered Establishments with LNH ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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