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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 K955185
Device Name GE ADVANTAGE DICOM CR REPROCESSING STATION
Applicant
GE Medical Systems
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact ALLEN SCHUH
Correspondent
GE Medical Systems
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact ALLEN SCHUH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/13/1995
Decision Date 01/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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