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 IDK151192
510k NumberK151192
Device Name:Syngo.via MI Workflows
ClassificationSystem, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC 2501 N. BARRINGTON ROAD Hoffman Estates,  IL  60192
ContactVeronica Padharia
CorrespondentVeronica Padharia
SIEMENS MEDICAL SOLUTIONS USA, INC 2501 N. BARRINGTON ROAD Hoffman Estates,  IL  60192
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-04
Decision Date2015-06-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.