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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 K111079
Device Name SYNGO.VIA WEB VIEWER
Applicant
Siemens AG Medical Solutions
Henkestrasse 127, D-91052
Eriangen,  DE
Applicant Contact SVEN KNOKE
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact NORBERT STUIBER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/18/2011
Decision Date 05/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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