Syngo.via MI WorkFlows, Scenium, Syngo MBF

Automated Radiological Image Processing Software

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, Scenium, Syngo Mbf.

Pre-market Notification Details

Device IDK211459
510k NumberK211459
Device Name:Syngo.via MI WorkFlows, Scenium, Syngo MBF
ClassificationAutomated Radiological Image Processing Software
Applicant Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville,  TN  37932
ContactClayton Ginn
CorrespondentClayton Ginn
Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville,  TN  37932
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-11
Decision Date2021-06-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869279800 K211459 000

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