Intended Use

Software-only medical device intended for use by technicians and trained physicians to derive contours of anatomical structures from computed tomography studies for input to a radiation treatment planning system, specifically for anatomical structures in the head & neck and thoracic body regions.

Technology

A cloud-deployed software-only device using deep learning contouring algorithms to automatically process non-contrast CT images and generate anatomical structure contours without human intervention; it operates independently of radiation treatment type or disease type in head, neck, and thoracic regions.

Performance

Performance testing included automated segmentation accuracy evaluation using DICE similarity coefficients and mean 95% Hausdorff Distance calculations, software verification and validation per IEC 62304 standards; no clinical or animal studies were required.

Predicate Devices

No predicate devices specified

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