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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 K960613
Device Name GE ADVANTAGE WINDOWS REVIEW WORKSTATION
Original Applicant
GE MEDICAL SYSTEMS
po box 414
milwaukee,  WI  53201
Original Contact larry a kroger, ph.d.
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/13/1996
Decision Date 04/30/1996
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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