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510(k) Data Aggregation

    K Number
    K152994
    Device Name
    Adaptivo
    Date Cleared
    2016-02-03

    (113 days)

    Product Code
    Regulation Number
    892.5050
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    Applicant Name (Manufacturer) :

    Aurora Technology Development, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It is to be used by a radiation oncology licensed medical professional as a guide to provide pre-treatment plan delivery verification; to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery: to provide estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and to aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals. Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans.
    Device Description
    Aurora Technology Development (ATD) Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It provides: • pre-treatment plan delivery verification; • the ability to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery; • estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and • an aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals. ATD Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans. ATD Adaptivo has two (2) primary software modules: (1) the Adaptive Dose Recalculation (ADR) module; and (2) the In-vivo Dosimetry (IVD) module. These two (2) modules integrate seamlessly to provide the user full benefit of ATD Adaptivo.
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