Intended Use

It is used by radiation oncology department to register multi-modality 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 employs deep learning for automatic contouring of organs-at-risk in head and neck, thorax, abdomen, and pelvis areas, and supports rigid and deformable image registration of multi-modality images. It also provides manual contouring and general image management tools including DICOM data handling, patient management, plan evaluation, and dose analysis.

Performance

Deformable registration performance was evaluated by comparing Normalized Mutual Information (NMI) values with a predicate device, showing non-inferior accuracy. Software verification, validation, and regression testing were performed successfully according to FDA guidance, with no clinical studies included.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    6/13/2022

    8 months
  • 2

    FDA Approval

    3/9/2023

Other devices from Manteia Technologies Co., Ltd.

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