syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.syngo.via RT Image Suite is a software tool designed to assist clinicians in viewing, manipulating, and contouring 3D and 4D medical images from various modalities such as CT, PET, MRI, and CBCT. It helps prepare radiation therapy treatment plans by enabling visualization, semi-automatic and automatic contouring of tumors and organs, image registration, and image fusion. The software improves workflow efficiency and treatment accuracy in radiation oncology.
Intended Use
syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation of treatments such as, but not limited to those performed with radiation (e.g., Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to view, create, edit, and modify contours of body regions including skin outline, targets and organs-at-risk, and create simple geometric treatment plans which can be exported to Treatment Planning Systems.
Technology
Image analysis software combining digital image processing and visualization tools such as multiplanar reconstruction, minimum intensity projection, volume rendering, freehand and semi-automatic contouring, automated contouring on CT images, multi-modality image fusion, and rigid/deformable registration. Supports multi-modality medical images including CT, PET, PET/CT, MRI, and Linac CBCT. Incorporates advanced AI-based autocontouring with training data from diverse clinical sources.
Performance
Software verification and validation was performed per FDA guidance. The AI-based autocontouring was evaluated on 413 subjects with manual ground-truth segmentations based on international contouring guidelines. Testing covered diverse geographic regions, scanner manufacturers, and imaging protocols. All tests met acceptance criteria for geometric overlap (Dice coefficient), supporting clinical safety and effectiveness of the autocontouring feature.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/12/2023
7 months - 2
FDA Approval
4/26/2024
Other devices from Siemens Medical Solutions USA, Inc.
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