FDA 510(k) Application Details - K063826

Device Classification Name System, Image Processing, Radiological

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510(K) Number K063826
Device Name System, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES, IL 60195-7372 US
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Contact FRANK POKROP
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/26/2006
Decision Date 01/12/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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