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510(k) Data Aggregation

    K Number
    K980826
    Device Name
    EQUIDOSE SOLID STATE DIODE DETECTORS
    Manufacturer
    CII MASTEK, INC.
    Date Cleared
    1998-06-01

    (90 days)

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

    CII MASTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EquiDose™ Solid State Diode Detectors are intended to be used for the collection of radiation beam data from radiation therapy treatment machines in air, water, or in other suitable material. The data acquired with this type of detector can be used to compile radiation beam data over time as part of a quality assurance program, to verify treatment machine energy and output, and to measure therapeutic doses delivered to patients during treatment. The EquilDose™ Solid State Diode Detector is intended to be used for the collection of radiation beam data from radiation-producing machines.
    Device Description
    MasTek's EquiDose™ Solid State Diode Detectors are classical solid state diode detectors used for verification measurements in radiation therapy. All of the diodes share the same design, manufacturing process, are made of the same materials and they are all waterproof. With the exception of their higher input impedance and standard 2 meter cable length, the EquiDose™ Solid State Diode Detectors are exactly the same as the predicate ISORAD™ Solid State Diode Detectors. EquiDose™ Solid State Diode Detectors, when connected to an appropriate electrometer like the PTW-UNIDOS, K951764, are used to collect and verify beam data from radiation therapy treatment machines and to verify therapeutic amounts of radiation delivered during treatments.
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