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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 K050943
Device Name GE VIEWPOINT
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact ALLEN SCHUH
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact ALLEN SCHUH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/14/2005
Decision Date 05/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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