Syngo.Via RT Image Suite is a software tool designed to help clinicians visualize, manipulate, and contour medical images from various imaging modalities such as CT, MRI, and PET. It supports 3D and 4D image visualization and assists with the segmentation of tumors and organs-at-risk to aid in radiation therapy planning and response assessment. The software incorporates AI techniques, including deep learning-based contouring, to improve the accuracy and efficiency of treatment preparation, thereby enhancing patient care in radiation therapy.
3D and 4D image visualization, multi-modality manipulation and contouring tool for preparation and response assessment of treatments performed with radiation therapy
Image analysis software combining digital image processing and visualization tools for multi-modality viewing, contouring, registration, multi-planar reconstruction, and synthetic CT generation. Features include manual and automatic contouring with a new deep learning adversarial network for improved segmentation, multi-modality image fusion, and treatment plan management.
Verification and validation testing demonstrated conformance with software safety standards and substantial equivalence to predicate device; non-clinical integration and functional tests confirmed device performance; clinical tests showed improved organ-at-risk segmentation accuracy using deep learning approach, with 100% detection for evaluated organs and high Dice coefficients.
No predicate devices specified
Submission
8/1/2019
FDA Approval
9/18/2019
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