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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 K022310
Device Name ADVANTAGE WINDOWS X-RAY/MR FUSION
Applicant
GE MEDICAL SYSTEMS, INC.
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact LARRY KROGER
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact WOLFRAM GMELIN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/17/2002
Decision Date 08/01/2002
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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