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510(k) Data Aggregation

    K Number
    K162629
    Device Name
    IQM Integral Quality Monitor (also IQM)
    Manufacturer
    Date Cleared
    2016-10-20

    (29 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRT SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IQM Integral Quality Monitor is a large-area ionization chamber intended to be used for quality assurance verification measurements and documentation of the treatment delivery accuracy (beam shape, position and dose) from medical linear accelerators used for intensity modulated radiation therapy. The data acquired by IQM is used to compare and verify a treatment dose (delivered dose) to the expected dose and to compile treatment delivery radiation beam data over time as part of a quality assurance program.
    Device Description
    The IQM System is designed for the verification of radiation therapy treatments delivered with a linear accelerator. The IQM consists of an electronic detector device and software used to control the device and to process and display the results. Comparisons may be made with expected / previously measured data, results reviewed and documented for quality assurance purposes, and deviations from the expected signal can be detected and reported. Where results can be presented on a segment by segment basis, the realtime reporting of results gives the user the opportunity to detect serious deviations still during treatment, potentially aiding radiation therapy professionals in increasing patient safety.
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