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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K132045
Device Name ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
Applicant
Ge Hungary Kft
3000 N Grandview
Division: Dba Ge Healthcare
Waukesha,  WI  53188
Applicant Contact STEPHEN SLAVENS
Correspondent
Ge Hungary Kft
3000 N Grandview
Division: Dba Ge Healthcare
Waukesha,  WI  53188
Correspondent Contact STEPHEN SLAVENS
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received07/02/2013
Decision Date 09/04/2013
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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