Syngo.CT Lung CAD

Lung Computed Tomography System, Computer-aided Detection

Siemens Medical Solutions, Inc

The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc with the FDA for Syngo.ct Lung Cad.

Pre-market Notification Details

Device IDK193216
510k NumberK193216
Device Name:Syngo.CT Lung CAD
ClassificationLung Computed Tomography System, Computer-aided Detection
Applicant Siemens Medical Solutions, Inc 65 Valley Stream Parkway Malvern,  PA  19355
ContactAbhineet Johri
CorrespondentAbhineet Johri
Siemens Medical Solutions, Inc 65 Valley Stream Parkway Malvern,  PA  19355
Product CodeOEB  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-21
Decision Date2020-03-09

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