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510(k) Data Aggregation

    K Number
    K212887
    Device Name
    RTapp
    Manufacturer
    Date Cleared
    2021-11-10

    (61 days)

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

    SegAna, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RTapp™ is a stand-alone software that provides a means for comparison of imaging data that is DICOM compliant. It allows the registration and display of medical images as an aid during use by radiation oncology.
    Device Description
    RTapp™ v2.0 is a stand-alone software medical device. RTapp analyzes and visualizes the day-to-day variations in a radiation therapy patient's individual anatomical structures and the effect of those changes on the treatment dose; it is an aid during use by radiation oncology. The RTapp software: - Automatically queries and retrieves treatment plan data and images from any DICOM compliant equipment. - Automatically processes all patient's treatment fractions, flagging and presenting an advance warning of treatment plans at risk with an email notification. - Monitors and evaluates treatment plan performance in real time by using the Plan Performance Dose Volume Histogram (DVH). The DVH projects the amount of dose to be delivered. - Displays Deformable Image Registration contours, cross correlation metrics and flagging of large deformations. - Projects when Organs At Risk will exceed dose constraints. - Dose estimation - Generates reports as PDF with images and graphs.
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