Syngo.CT CaScoring

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 Cascoring.

Pre-market Notification Details

Device IDK201034
510k NumberK201034
Device Name:Syngo.CT CaScoring
ClassificationSystem, X-ray, Tomography, Computed
Applicant Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville,  TN  37932
ContactTabitha Estes
CorrespondentTabitha Estes
Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville,  TN  37932
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-20
Decision Date2020-05-14

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