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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 K020483
Device Name ADVANTAGE WORKSTATION 4.1
Applicant
GE MEDICAL SYSTEMS
800 BUSINESS CENTER DR.
MOUNT PROSPECT,  IL  60056
Applicant Contact SCOTT R EVANS
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 Received02/13/2002
Decision Date 02/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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