Intended Use

It is used by radiation oncology department to register multimodality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.

Technology

AccuContour is a standalone software that includes deep learning based automatic contouring of organs at risk on non-contrast CT images, multimodal image registration (CT/MR/PET), and manual contouring. It supports DICOM 3.0, allows image management and editing, and operates on Windows systems.

Performance

Performance testing demonstrates non-inferiority of AccuContour's segmentation and registration accuracy compared to a predicate device. Segmentation assessed by Dice similarity coefficients and registration by Normalized Mutual Information showed comparable results across diverse datasets from US and China using major vendor scanners (GE, Siemens, Philips).

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    7/19/2019

    7 months
  • 2

    FDA Approval

    2/28/2020

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