Syngo.via MI Workflows VB40A, Scenium

System, Image Processing, Radiological

Siemens Medical Soultions USA, Inc.

The following data is part of a premarket notification filed by Siemens Medical Soultions Usa, Inc. with the FDA for Syngo.via Mi Workflows Vb40a, Scenium.

Pre-market Notification Details

Device IDK191309
510k NumberK191309
Device Name:Syngo.via MI Workflows VB40A, Scenium
ClassificationSystem, Image Processing, Radiological
Applicant Siemens Medical Soultions USA, Inc. 2501 N. Barrington Road Hoffman Estates,  IL  60192
ContactVeronica Padharia
CorrespondentVeronica Padharia
Siemens Medical Soultions USA, Inc. 2501 N. Barrington Road Hoffman Estates,  IL  60192
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-14
Decision Date2019-07-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869243405 K191309 000
04056869243399 K191309 000
04056869243382 K191309 000
04056869243375 K191309 000
04056869243368 K191309 000
04056869243351 K191309 000

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