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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K032096
Device Name PHILIPS VIEWFORUM 2003
Applicant
PHILIPS MEDICAL SYSTEMS
22100 BOTHELL EVERETT HWY
P.O. BOX 3003
BOTHELL,  WA  98041 -8431
Applicant Contact LYNN T HARMER
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/08/2003
Decision Date 07/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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