FDA 510(k) Application Details - K983110

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K983110
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant TOSHIBA AMERICA MRI, INC.
280 UTAH AVE.
SOUTH SAN FRANCISCO, CA 94080-6883 US
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Contact KEN NEHMER
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 09/04/1998
Decision Date 02/25/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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