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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 K052345
Device Name ADVANTAGE SIM MD
Applicant
GE HEALTHCARE
3000 N. GRANDVIEW BLVD
WAUKESHA,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
INTERTEK TESTING SERVICES
70 CODMAN HILL RD.
BOXBOROUGH,  MA  01719
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received08/26/2005
Decision Date 09/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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