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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 K122164
Device Name MR VESSELLQ XPRESS
Applicant
GE MEDICAL SYSTEMS SCS
3000 NORTH GRANDVIEW
W1140
WAUKESHA,  WI  53188
Applicant Contact HELEN PENG
Correspondent
GE MEDICAL SYSTEMS SCS
3000 NORTH GRANDVIEW
W1140
WAUKESHA,  WI  53188
Correspondent Contact HELEN PENG
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
LNH  
Date Received07/20/2012
Decision Date 09/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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