FDA 510(k) Application Details - K063267

Device Classification Name System, Image Processing, Radiological

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510(K) Number K063267
Device Name System, Image Processing, Radiological
Applicant STENTOR INC., A PHILIPS MEDICAL SYSTEMS CO.
5000 MARINA BLVD.
SUITE 100
BRISBANE, CA 94005 US
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Contact DEANA WISEMAN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 10/30/2006
Decision Date 11/09/2006
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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