FDA 510(k) Application Details - K123922

Device Classification Name System, Image Processing, Radiological

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510(K) Number K123922
Device Name System, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
400 W. MORGAN ROAD
SUITE 100
ANN ARBOR, MI 48108-9117 US
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Contact YURI IKEDA
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/20/2012
Decision Date 01/16/2013
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 Y
Expedited Review



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