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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 K093234
Device Name INTEGRATED REGISTRATION
Applicant
GE MEDICAL SYSTEMS SCS
283 RUE DE LA MINIERE BP 34
BUC CEDEX,  FR 78533
Applicant Contact SOPHIE LE LOARER
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/15/2009
Decision Date 10/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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