Syngo.CT Lung CAD

Lung Computed Tomography System, Computer-aided Detection

Siemens Healthcare GmbH

The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo.ct Lung Cad.

Pre-market Notification Details

Device IDK203258
510k NumberK203258
Device Name:Syngo.CT Lung CAD
ClassificationLung Computed Tomography System, Computer-aided Detection
Applicant Siemens Healthcare GmbH Siemensstr. 1 Forchheim,  DE 91301
ContactAbhineet Johri
CorrespondentAbhineet Johri
Siemens Healthcare GmbH Siemensstr. 1 Forchheim,  DE 91301
Product CodeOEB  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-05
Decision Date2021-03-31

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