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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 K152352
Device Name Stereo 3D option for Vision Applications
Applicant
GE MEDICAL SYSTEMS, SCS
283 RUE DE LA MINIERE
BUC,  FR 78530
Applicant Contact NING WEN
Correspondent
GE MEDICAL SYSTEMS, SCS
283 RUE DE LA MINIERE
BUC,  FR 78530
Correspondent Contact John Jaeckle
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
OWB  
Date Received08/20/2015
Decision Date 01/20/2016
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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