Syngo.CT Dual Energy

System, X-ray, Tomography, Computed

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.ct Dual Energy.

Pre-market Notification Details

Device IDK191468
510k NumberK191468
Device Name:Syngo.CT Dual Energy
ClassificationSystem, X-ray, Tomography, Computed
Applicant Siemens Medical Solutions, USA, Inc 2501 N. Barrington Road Hoffman Estates,  IL  60192
ContactCynthia Busch
CorrespondentCynthia Busch
Siemens Medical Solutions, USA, Inc 2501 N. Barrington Road Hoffman Estates,  IL  60192
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-03
Decision Date2019-07-03

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