VisAble.IO is a software tool that helps doctors plan and confirm liver ablation procedures using CT images. It provides features like segmentation of liver structures, virtual placement of ablation needles, and analysis of ablation zones to support clinicians during treatment. It is designed to improve the accuracy and efficiency of liver ablation therapy planning and evaluation in clinical settings.
Intended Use
VisAble.IO is a Computed Tomography (CT) image processing software package available for use with liver ablation procedures. It assists physicians in planning liver ablation procedures, including identifying ablation targets and virtual needle placement, and confirming ablation zones. The software is not intended for diagnosis or to predict ablation success.
Technology
VisAble.IO is a stand-alone software that imports CT images from scanners or PACS, performs manual and automated segmentation of liver anatomy and ablation zones, supports virtual needle planning, image registration of pre- and post-ablation images, and quantitative analysis including margin and volume measurements.
Performance
Performance testing included segmentation, image registration, and measurement validations using multiple clinical datasets across international sites. The liver and vessel segmentation use AI algorithms validated with Dice scores ranging from 0.70 to 0.98. The software meets user needs and predicate device performance with mitigated risks identified by use-related risk analysis.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/5/2022
8 months - 2
FDA Approval
8/28/2023
Other devices from TechsoMed
- VisAble.IO2024 • 510K
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