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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K133649
Device Name HEPATIC VCAR
Applicant
GE MEDICAL SYSTEMS SCS
3000 N. GRANDVIEW
WAUKESHA,  WI  53188
Applicant Contact HUY DOAN
Correspondent
GE MEDICAL SYSTEMS SCS
3000 N. GRANDVIEW
WAUKESHA,  WI  53188
Correspondent Contact HUY DOAN
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
LLZ  
Date Received11/27/2013
Decision Date 04/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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