syngo.CT Coronary Cockpit
Siemens Medical Solutions USA, Inc.syngo.CT Coronary Cockpit is a software tool designed to assist doctors in analyzing cardiac CT angiography images. It combines automated and semi-automated processing to help detect, evaluate, document, and plan treatment for coronary artery disease. This software integrates with existing imaging systems and supports visualization and reporting to improve clinical workflow and decision-making.
Intended Use
An image analysis software package for evaluating cardiac CT angiography volume data sets combining automated and semi-automated image processing, visualization and reporting tools to assist physicians in confirming coronary lesions for evaluation, documentation, follow-up and treatment planning.
Technology
The software operates as a plug-in to the syngo.via MM Reading application, providing automated centerline tracing, lumen and vessel wall segmentation, lesion evaluation, plaque classification, quantification, remodeling index calculation, and reporting. It supports 2D/3D visualization, CPR, cross-sections, and spectral imaging integration. It applies AI algorithms trained on multi-vendor datasets for coronary vessel tracing and plaque assessment.
Performance
The device's coronary vessel tracing and lumen/wall segmentation algorithms were validated on multi-vendor CT datasets (n=425), annotated by expert radiologists/cardiologists. Results showed high sensitivity (~95.8%), precision (~96.1%), and strong correlation (Pearson’s r >0.7) for lumen volume, diameter, stenosis grading, and plaque quantification. Software verification and risk analysis were completed successfully, asserting substantial equivalence and safety.
Predicate Devices
No predicate devices specified
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