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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 K110834
Device Name AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
Original Applicant
GE HEALTHCARE
3000 north.grandview blvd.
w1140
waukesha,  WI  53188
Original Contact helen peng
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/25/2011
Decision Date 04/26/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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