Intended Use

AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR pre-defined structures using deep-learning-based algorithms. Contours are used as input for external beam radiation therapy planning and must be reviewed by medical professionals.

Technology

Provides automatic segmentation of Organs-at-Risk from CT or MR images using deep learning algorithms. Processes DICOM data, outputs DICOMRTSTRUCT contour sets. Software integrates with treatment planning systems for review and editing of contours.

Performance

Performance validated on 579 CT cases and 66 MR cases from diverse, multi-center datasets. Metrics include Dice coefficient and surface distance, showing comparable or improved results vs predicate device. Nonclinical bench testing, software validation and risk analysis were also performed. Human factors testing confirmed usability by trained clinicians.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    9/11/2024

    6 months
  • 2

    FDA Approval

    3/27/2025

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