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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 K983256
Device Name ADVANTAGE WINDOWS (AW) FUSION
Original Applicant
GE MEDICAL SYSTEMS
p.o. box 414
milwaukee,  WI  53188
Original Contact larry a kroger
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/16/1998
Decision Date 12/15/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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