Intended Use

AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.

Technology

AutoContour consists of three components: a Windows agent service that uploads CT datasets to a cloud-based automatic contouring service using machine learning algorithms, and a web application for manual registration, review, and editing of contours. It supports CT imaging modalities primarily, with MR and PET inputs for registration only, producing DICOM RTSTRUCT output for radiation therapy planning.

Performance

No clinical trials were conducted; performance was validated using verification and validation tests including testing with independent datasets to demonstrate accuracy and generalizability of the machine learning model, ensuring that the software performs as intended with pass/fail criteria.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    2/10/2020

    8 months
  • 2

    FDA Approval

    10/30/2020

Other devices from Radformation, Inc.

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