VisAble.IO is a software tool that helps physicians plan and evaluate liver ablation treatments by processing CT and MRI images. It assists in identifying treatment targets, planning needle placement virtually, and confirming the treatment area post-procedure to improve procedure accuracy and patient outcomes.
Intended Use
VisAble.IO is a CT and MR image processing software package available for use with liver ablation procedures. It assists physicians in planning ablation procedures, including identifying ablation targets and virtual needle placement, and assists in confirming ablation zones. Not intended for diagnosis or prediction of ablation success.
Technology
VisAble.IO is a standalone software application running on a dedicated computer, designed to assist users in planning liver ablation procedures and treatment confirmation. It supports image import from CT and MR scanners, provides tools for image segmentation, virtual instrument placement, image registration, and quantitative analysis. It uses AI algorithms for segmentation of liver and vessels and offers manual and automated tools for segmentation, registration, and quantification.
Performance
Performance testing included validation of segmentation accuracy (mean DICE scores between 0.70-0.98), image registration accuracy (mean corresponding distance ~4-8 mm), and other functional testing. AI models were trained on large multicenter datasets with diverse patient populations and imaging systems. Verification and validation were performed according to FDA and industry standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/21/2024
25 days - 2
FDA Approval
4/15/2024
Other devices from Techsomed
- VisAble.IO2023 • 510K
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