FDA 510(k) Application Details - K050132

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K050132
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC.
16809 BRIARDALE ROAD
ROCKVILLE, MD 20855 US
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Contact THOMAS M TSAKERIS
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 01/21/2005
Decision Date 02/15/2005
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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