Intended Use

The MOZI Treatment Planning System (MOZI TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. MOZI TPS is used to plan external beam irradiation with photon beams.

Technology

MOZI TPS is standalone software that includes core functions such as image processing, automatic rigid and deformable registration, deep learning-based automatic contouring, plan design, Monte Carlo dose calculation, optimization, and evaluation for radiotherapy treatment planning.

Performance

Comprehensive performance testing included software validation, Monte Carlo dose calculation accuracy, automatic rigid and deformable registration accuracy compared to predicate and reference devices, segmentation performance measured by Dice Similarity Coefficient across various organs, end-to-end testing with patient cases, and compliance with IEC 62083-2009 standard. Results demonstrated equivalence or superiority to predicate and reference devices.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/13/2022

    6 months
  • 2

    FDA Approval

    7/10/2023

Other devices from Manteia Technologies Co., Ltd.

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