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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 K121827
Device Name GSI VIEWER WITH VUE OPTION
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 Number892.1750
Classification Product Code
JAK  
Date Received06/21/2012
Decision Date 09/13/2012
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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