Device Dossier

Radiation therapy treatment planning system, application program software

Device Dossier for Radiation therapy treatment planning system, application program software (Radiation therapy software, Class IIb, sponsor Taevas Life…

Intended purpose

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.

TGA Public Summary