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Found 3 results
510(k) Data Aggregation
K Number
K241837Device Name
Limbus Contour
Manufacturer
Limbus AI Inc.
Date Cleared
2024-10-09
(106 days)
Product Code
QKB
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Limbus AI Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. The Limbus Contour Software assists in the following scenarios:
Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning.
Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up.
Localization and definition of healthy anatomical structures.
Limbus Contour is not intended for use with digital mammography.
Device Description
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 (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
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K Number
K230575Device Name
Limbus Contour
Manufacturer
Limbus AI Inc.
Date Cleared
2023-04-07
(37 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Limbus AI Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. The Limbus Contour Software assists in the following scenarios: Operates in conjunction with radiation treatment planning systems to load, save, and display medical images and contours for treatment evaluation and treatment planning. Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. Localization and definition of healthy anatomical structures. Limbus Contour is not intended for use with digital mammography.
Device Description
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 postprocessing 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).
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K Number
K201232Device Name
Limbus Contour
Manufacturer
Limbus AI Inc.
Date Cleared
2020-08-13
(98 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Limbus AI Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. The Limbus Contour Software assists in the following scenarios:
· Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning.
· Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up.
· Localization and definition of healthy anatomical structures.
Limbus Contour is not intended for use with digital mammography.
Limbus Contour is not intended to automatically contour tumor clinical target volumes.
Device Description
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 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).
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