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FDA-cleared K241837

Limbus Contour

Limbus AI Inc.

Authorized purpose: Limbus Contour v1.8.0 assists trained radiation oncologists, dosimetrists, and physicists by generating CT and MR anatomical contours locally on Windows systems for review and DICOM RT Structure Set transfer into treatment planning.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-10-09
FDA-cleared K230575

Limbus Contour

Limbus AI Inc.

Authorized purpose: Limbus Contour assists trained radiation oncologists, dosimetrists, and physicists by generating CT and MR healthy-anatomy contours on Windows systems for review and DICOM RT Structure Set transfer into treatment planning.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-04-07
FDA-cleared K201232

Limbus Contour

Limbus AI Inc.

Limbus Contour assists trained radiation oncologists, dosimetrists, and physicists by generating anatomical contours from CT and MR images for radiation-treatment planning. The initial cleared release provided CT and MR automatic contouring on Windows and macOS, used file-system DICOM import and RT Structure Set export, and excluded tumor and tumor-CTV automatic contouring.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-08-13