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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 K132532
Device Name SYNGO.PLAZA VB10A
Applicant
SIEMENS AG HEALTHCARE
HENKESTRASSE 127
ERLANGEN,  DE 91052
Applicant Contact VIKTORIA BENZ
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 Received08/12/2013
Decision Date 12/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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