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510(k) Data Aggregation

    K Number
    K191610
    Device Name
    RTapp
    Manufacturer
    Date Cleared
    2019-10-01

    (106 days)

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

    SegAna, LLC

    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 v1.0 is a stand-alone, cloud-based software medical device with secure access via a private internet web portal. RTqpp 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; 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. RTapp is intended for use by radiation oncology professionals in a hospital/clinical setting for any patient undergoing radiation therapy based on a treatment plan. RTapp is NOT intended as a treatment planning software and cannot be used to generate radiotherapy treatment plans.
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