Syngo.via MI Workflows

System, Image Processing, Radiological

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.via Mi Workflows.

Pre-market Notification Details

Device IDK160426
510k NumberK160426
Device Name:Syngo.via MI Workflows
ClassificationSystem, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates,  IL  60192
ContactVeronica Padharia
CorrespondentVeronica Padharia
SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates,  IL  60192
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-16
Decision Date2016-03-04
Summary:summary

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