Intended Use

3D and 4D image visualization, multi-modality manipulation and contouring tool for preparation and response assessment of treatments performed with radiation therapy

Technology

Image analysis software combining digital image processing and visualization tools for multi-modality viewing, contouring, registration, multi-planar reconstruction, and synthetic CT generation. Features include manual and automatic contouring with a new deep learning adversarial network for improved segmentation, multi-modality image fusion, and treatment plan management.

Performance

Verification and validation testing demonstrated conformance with software safety standards and substantial equivalence to predicate device; non-clinical integration and functional tests confirmed device performance; clinical tests showed improved organ-at-risk segmentation accuracy using deep learning approach, with 100% detection for evaluated organs and high Dice coefficients.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/1/2019

    1 month
  • 2

    FDA Approval

    9/18/2019

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