Intended Use

Post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms for external beam radiation therapy treatment planning.

Technology

Deep learning-based algorithm processes DICOM CT images to automatically segment organs at risk, outputting RTSTRUCT objects for radiation oncology use. The system uses a web-based interface for settings and progress management and supports multi-detector CT scans with recommended slice counts.

Performance

Performance testing included segmentation accuracy validation on retrospective CT datasets from Taiwan and the USA from multiple vendors, achieving median Dice similarity coefficients greater than 0.80 for major organs at risk. No clinical tests were conducted. The software met acceptance criteria for reliable and accurate contouring, regardless of contrast enhancement.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    6/23/2023

    7 months
  • 2

    FDA Approval

    2/13/2024

Other devices from Quanta Computer Inc.

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