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510(k) Data Aggregation

    K Number
    K161807
    Device Name
    BEAMSCAN
    Date Cleared
    2017-05-19

    (322 days)

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

    PTW-Freiburg Physikalisch Technische-Werksraetten

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BEAMSCAN system is intended to collect beam data in water under the aspect of machine QA for the following purposes: - acceptance testing and/or commissioning of a radiation therapy system. - measurements after repair or replacement of major treatment unit components. - beam data analysis according to international therapy dosimetry protocols. - acquisition, formatting and transfer of basic data to treatment planning systems. - periodic QA procedures, e.g. constancy checks.
    Device Description
    The BEAMSCAN system is comprised of a PMMA tank with a moving mechanism and a radiation detector. Further main components are a lifting carriage with built-in electrometer and control unit with separate control pendant. The lifting carriage either includes a water reservoir or a separate reservoir is used. A positioning device can be mounted on top of the lifting carriage and allows the water phantom to be aligned manually. The whole system is controlled with software for data display and processing.
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