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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 K052995
Device Name ADVANTAGE WORKSTATION 4.3.
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 Number892.2050
Classification Product Code
LLZ  
Date Received10/25/2005
Decision Date 11/08/2005
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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