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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 K042334
Device Name ALLURA 3D-CA, RELEASE 1
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003, MS 915
BOTHELL,  WA  98041 -3003
Applicant Contact LYNN HARMER
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact MARC MOUSER
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
IZI  
Date Received08/30/2004
Decision Date 09/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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