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 IDK133644
510k NumberK133644
Device Name:SYNGO.VIA MI WORKFLOWS
ClassificationSystem, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 810 INNOVATION DR. Knoxville,  TN  37932
ContactAlaine Medio, Rac
CorrespondentAlaine Medio, Rac
SIEMENS MEDICAL SOLUTIONS USA, INC. 810 INNOVATION DR. Knoxville,  TN  37932
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-27
Decision Date2014-02-25
Summary:summary

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