Syngo Dynamics Version VA30

System, Image Processing, Radiological

Siemens Healthcare GmbH

The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo Dynamics Version Va30.

Pre-market Notification Details

Device IDK171053
510k NumberK171053
Device Name:Syngo Dynamics Version VA30
ClassificationSystem, Image Processing, Radiological
Applicant Siemens Healthcare GmbH Henkestrasse 127 Erlangen,  DE 91052
ContactLauren Bentley
CorrespondentAlexander Schapovalov
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2017-04-10
Decision Date2017-06-01
Summary:summary

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