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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 K143368
Device Name GenIQ
Applicant
GE MEDICAL SYSTEMS, LLC.
3200 N. GRANDVIEW BLVD
WAUKESHA,  WI  53188
Applicant Contact Jenny Wong
Correspondent
GE MEDICAL SYSTEMS, LLC.
3200 N. GRANDVIEW BLVD
WAUKESHA,  WI  53188
Correspondent Contact Jenny Wong
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/25/2014
Decision Date 07/29/2015
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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