Limbus Contour
Limbus AI Inc.Limbus Contour is a software tool that automatically segments CT and MRI images to help radiation oncologists, dosimetrists, and medical physicists create precise contours of healthy anatomical structures. These contours are used as inputs for radiation treatment planning, improving accuracy and efficiency in therapy. The software integrates with existing treatment planning systems and image viewers, assisting in contour creation, modification, and management without displaying images directly.
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 using CT and MRI images. It assists in loading, saving, displaying medical images and contours; creating, transforming, modifying contours; and localizing and defining healthy anatomical structures.
Technology
Limbus Contour is a standalone software application that uses pre-trained and expert-curated machine learning models to automatically segment (contour) normal tissues on CT and MRI DICOM images. The software outputs segmented contours in DICOM RT-Structure Set format and operates alongside existing radiotherapy treatment planning and DICOM viewing systems. It does not display or store images itself and interfaces with the user's operating system for file importing and exporting.
Performance
Performance testing included manual and automated software verification and validation, demonstrating that all software requirements were met and that the device performs automatic contouring accurately and reliably for its intended use. No clinical or animal testing was required; safety and effectiveness rely on bench testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/1/2023
1 month - 2
FDA Approval
4/7/2023
Other devices from Limbus AI Inc.
- Limbus Contour2024 • 510K
- Limbus Contour2020 • 510K
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