Limbus Contour
Limbus AI Inc.Limbus Contour is a software tool that uses machine learning to automatically create contours of normal anatomical structures on CT and MRI images for use in radiation therapy planning. It helps trained clinicians by providing optimized contours that can be imported into treatment planning systems, improving efficiency and accuracy in defining healthy tissues.
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. Supported image modalities are Computed Tomography and Magnetic Resonance.
Technology
Limbus Contour is a stand-alone software application that automatically contours normal tissues on CT and MR DICOM images using pre-trained, expert-curated machine learning models with post-processing. It imports DICOM image files and exports segmented RT-Structure Set files for external use in radiation treatment planning systems. It does not display images but relies on existing systems for visualization and modification.
Performance
Performance testing included manual and automated verification and validation tests, validating automatic contouring function. All tests passed and demonstrated that the software meets user needs and intended uses, supporting substantial equivalence to a predicate device. No clinical testing was required as bench testing was sufficient.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/7/2020
3 months - 2
FDA Approval
8/13/2020
Other devices from Limbus AI Inc.
- Limbus Contour2024 • 510K
- Limbus Contour2023 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.