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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameTESLACON(TM) NMR IMAGING SYSTEM
Classification Namesystem, nuclear magnetic resonance imaging
Generic Namenuclear magnetic resonance imaging system
Regulation Number892.1000
ApplicantTECHNICARE CORP.
PMA NumberP830051
Supplement NumberS012
Date Received08/18/1986
Decision Date11/05/1986
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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