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510(k) Data Aggregation

    K Number
    K213155
    Device Name
    RT-Mind-AI
    Date Cleared
    2021-12-15

    (78 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedMind Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    It is used by radiation oncology department to segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation
    Device Description
    The proposed device, RT-Mind-AI, is a standalone software which used by radiation oncology department to segment (non-contrast) CT images, to generate needed information for treatment planning. treatment evaluation and treatment adaptation. The proposed device has four main function: 1) Deep learning contouring: Automatic segment on desktop: it can automatically contour the organ-at-risk (ORA), including Head and Neck, thorax and abdominal and pelvic. Automatic segment on the Web: it can realize automatic contouring the OAR on the web and A sending to the specified network node in a local area network (LAN). Note: only the administrator account and operator accounts can carry out the automatic segment on the Web. Manual segment: Adjust the segment result after automatic segment. 2) It also has the following general functions: A Preset ROIs > Preset templates > Transmit DICOM data: > Desktop patient management > Review images; A ROI management; > Web-based patient management A Open and save of files.
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