syngo.via RT Image Suite
Siemens Medical Solutions USA Inc.The syngo.via RT Image Suite by Siemens is a software tool that helps clinicians visualize, manipulate, and contour medical images in 3D and 4D across multiple imaging modalities. It supports the preparation of radiation therapy treatments by allowing the viewing and editing of contours for tumors and organs-at-risk, managing points of interest, and generating synthetic CT images using AI algorithms. This tool improves the accuracy and efficiency of treatment planning for patients undergoing radiation therapy.
Intended Use
syngo.via RT Image Suite is 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. It allows viewing, creating, editing, modifying, and copying contours of regions such as skin outline, targets, and organs-at-risk, and enables creation of simple geometric treatment plans.
Technology
The software includes image processing and visualization capabilities such as multi-modality viewing, multiplanar reconstruction, volume rendering (VRT), freehand and semi-automatic contouring on any orientation, automated contouring on CT, image registration (rigid and deformable), multi-modality image fusion, contouring of moving tumors, point management, and synthetic CT generation from multiple pre-defined MR acquisitions using an AI-based deep learning algorithm.
Performance
Performance testing included software verification and validation according to FDA guidance for medical device software, non-clinical integration and functional tests, and specific evaluation of the AI-based synthetic CT generation algorithm demonstrating high geometric fidelity and HU accuracy superior to the predicate device. Risk analysis and hazard mitigations were completed. All testing supported the substantial equivalence and safety of the device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/4/2021
2 months - 2
FDA Approval
7/30/2021
Other devices from Siemens Medical Solutions USA Inc.
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