Syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.Syngo.via RT Image Suite is a medical imaging software tool that helps clinicians visualize and manipulate 3D and 4D images from multiple modalities like CT, PET, and MRI in preparation for radiation therapy treatments. It provides advanced contouring tools including AI-based automatic organ segmentation, multi-modality image fusion, and supports creating treatment plans to improve accuracy and efficiency in radiation therapy workflows.
Intended Use
A 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation of treatments such as radiation therapy including Brachytherapy, Particle Therapy, and External Beam Radiation Therapy.
Technology
Image analysis software providing multi-modality viewing and contouring of anatomical, functional, and multi-parametric images. Includes multiplanar reconstruction, semi-automatic and automatic contouring, registration using rigid and deformable alignment, multi-modality image fusion, and AI-based segmentation with a deep image-to-image network.
Performance
Software verification and validation including risk analysis confirmed software meets acceptance criteria. Non-clinical performance tested with integration and functional tests. AI-based automated organ segmentation algorithm was evaluated on 112 subjects showing detection and segmentation performance comparable or superior to predicate device, confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/1/2020
2 months - 2
FDA Approval
8/13/2020
Other devices from Siemens Medical Solutions USA, Inc.
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