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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 K171053
Device Name syngo Dynamics Version VA30
Applicant
Siemens Healthcare GmbH
Henkestrasse 127
Erlangen,  DE 91052
Applicant Contact Lauren Bentley
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact Alexander Schapovalov
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/10/2017
Decision Date 06/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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