syngo.via RT Image Suite
Siemens Medical Solutions USA Inc.The syngo.via RT Image Suite by Siemens is advanced software that helps clinicians visualize and manipulate 3D and 4D medical images from multiple modalities like CT, MRI, PET, and CBCT. It supports contouring tumors and organs at risk, image registration, and creating simple treatment plans, aiding radiation therapy preparation. The software includes AI-based deep learning for lung lobe segmentation to calculate lung ventilation, improving the accuracy and efficiency of radiation therapy planning.
Intended Use
3D and 4D image visualization, multi-modality manipulation and contouring tool to help preparation of radiation therapy treatments including Brachytherapy, Particle Therapy, External Beam Radiation Therapy by viewing, creating, modifying, and copying contours of body regions and organs-at-risk.
Technology
Image analysis software that supports viewing and manipulation of multi-modality medical images including CT, PET/CT, MRI, and CBCT; provides 3D/4D visualization, freehand and semi-automatic contouring; manual and automated image registration (rigid and deformable); multi-modality fusion; and AI-based deep learning for lung lobe segmentation to calculate lung ventilation. It includes tools for patient marking, contour editing, treatment plan creation, and synthetic CT generation from MR data.
Performance
Verification and validation testing was performed according to FDA guidelines for software in medical devices, including risk analysis and clinical validation of the AI-based lung ventilation algorithm. The AI segmentation model was trained and validated on thousands of CT scans and tested on independent datasets, achieving a mean DICE of 0.92. Clinical validation correlated ventilation results with spirometry, showing significant correlation supporting clinical relevance. Non-clinical testing demonstrated software functions as intended, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/17/2022
5 months - 2
FDA Approval
9/7/2022
Other devices from Siemens Medical Solutions USA Inc.
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