FDA 510(k) Application Details - K023137

Device Classification Name System, Image Processing, Radiological

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510(K) Number K023137
Device Name System, Image Processing, Radiological
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL, WA 98041-3003 US
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Contact LYNN HARMER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/20/2002
Decision Date 12/19/2002
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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