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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
Applicant
GE HEALTHCARE
3000 NORTH.GRANDVIEW BLVD.
W1140
WAUKESHA,  WI  53188
Applicant Contact HELEN PENG
Correspondent
GE HEALTHCARE
3000 NORTH.GRANDVIEW BLVD.
W1140
WAUKESHA,  WI  53188
Correspondent 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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