syngo.CT Lung CAD (Version VD30)
Siemens Healthcare GmbHsyngo.CT Lung CAD (Version VD30) is a computer-aided detection tool developed by Siemens Healthcare GmbH to help radiologists identify solid and subsolid pulmonary nodules in chest CT scans. The software highlights regions that might be overlooked, improving the accuracy and efficiency of lung nodule detection during radiological review. It can operate as a first or second reader and includes a mode to filter out subsolid and fully calcified nodules for focused analysis.
Intended Use
The syngo.CT Lung CAD software device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of pulmonary nodules during review of multi-detector computed tomography (MDCT) examinations of the thorax (chest). The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may otherwise be overlooked.
Technology
The software uses convolutional neural networks (CNN) for lung segmentation, candidate generation, candidate classification, and post-filtering to detect and classify pulmonary nodules (solid, subsolid, fully calcified) from chest CT images. It integrates with visualization applications to display CAD marks. The VD30 version includes an additional 'solid-only' mode that filters out subsolid and fully calcified nodules.
Performance
Performance testing included retrospective evaluation on 712 CT thoracic cases from multiple sources, demonstrating non-inferior sensitivity and significantly lower false positives compared to the predicate device VD20. Testing included statistical analysis, software verification and validation, and risk analysis supporting substantial equivalence and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/24/2023
2 months - 2
FDA Approval
7/19/2023
Other devices from Siemens Healthcare GmbH
- Syngo Carbon Enterprise Access (VA40A)2024 • 510K
- AI-Rad Companion (Pulmonary)2024 • 510K
- Syngo Carbon Clinicals2023 • 510K
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