FDA 510(k) Application Details - K042867

Device Classification Name System, Image Processing, Radiological

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510(K) Number K042867
Device Name System, Image Processing, Radiological
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
22100 BOTHELL EVERETT HIGHWAY
BOTHELL, WA 98021-8431 US
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Contact LYNN T HARMER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 10/18/2004
Decision Date 11/02/2004
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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