Limbus Contour
Limbus AI Inc.Limbus Contour is a software tool designed to help medical professionals automatically create accurate contours of healthy anatomical structures from CT and MRI images. These contours are used to plan and evaluate radiation treatment for cancer patients, improving efficiency and consistency in treatment preparation.
Intended Use
Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. It operates with CT and MR images to assist contouring and treatment planning.
Technology
A stand-alone, cross-platform software application leveraging locked deep learning models (U-Net and ResUNet architectures) trained on over 10,000 scans with expert-labeled contours. It imports DICOM CT/MRI images and outputs DICOM RT-Structure Set files for integration with radiation treatment planning systems. No image visualization is provided; it depends on external viewers for review and modification of contours.
Performance
Performance validation involved benchtop testing against expert manual contours on multiple anatomical structures across supported body regions and image modalities. Dice Similarity Coefficients (DSC) for all tested structures met or exceeded reference thresholds, demonstrating accuracy and minimal editing required. Thousands of structures were analyzed, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/25/2024
3 months - 2
FDA Approval
10/9/2024
Other devices from Limbus AI Inc.
- Limbus Contour2023 • 510K
- Limbus Contour2020 • 510K
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