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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 K150843
Device Name syngo®.via (version VB10A)
Applicant
Siemens AG
Henkestrasse 127
Erlangen,  DE 91052
Applicant Contact Martin Meyer
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact DAWN M TIBODEAU
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/30/2015
Decision Date 04/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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