limbus.aiLimbus Contour
Limbus Ai, Inc.
LIMBUS AI
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017927156 | 3017927156 | LIMBUS AI | 1 | N | 2026-01-01 | 30 Adelaide St. East - 12th Floor Toronto Ontario CA M5C 3G8 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00628011382146 | Limbus Contour - Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). | 8336680077 | support@limbus.ai |
| 00628011382153 | Limbus Contour - Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). | 8336680077 | support@limbus.ai |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 286933 | 2065124402 | K241837 | Limbus Contour | QKB | 2024-10-09 |
| 286933 | 1791711635 | K230575 | Limbus Contour | LLZ | 2023-04-07 |
| 286933 | 1131870066 | K201232 | Limbus Contour | LLZ | 2020-08-13 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Limbus Contour - Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine leaming models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image.dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
2025-02-19
Limbus Contour - Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
2023-04-14
Limbus Contour - Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
2022-05-09
Limbus Contour - Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
2021-10-29
Limbus Contour - Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
2021-06-09