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510(k) Data Aggregation

    K Number
    K013897
    Device Name
    SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
    Manufacturer
    Date Cleared
    2002-05-21

    (179 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-SCAN S.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Models IRIS 20 or IRIS 41 SSXI detector combined with IRIS-View Image Acquisition control, display viewing, and archiving console is indicated for use as a SSXI Portal Imaging Device used in conjunction with Medical Accelerator Radiotherapy Devices as an alternative to Conventional Portal Film.
    Device Description
    The IRIS flat panel X-ray detector is available in two sizes, 20 x 20 cm (IRIS 20) and 41 x 41 cm (IRIS 41), with an Element Matrix of 256 x 256 and 1024 x 1024 respectively. X-rays are converted to light using a Gd202S(Tb) opto-mechanical luminescent screen coupled to an Amorphous Silicon Thin Transistor Photodiode Integrating Storage Matrix Array. The IRIS-View console accepts the digital signals from the detectors through a PC card interface into a standard PC with a Microsoft Windows operating system. Software processing of the data is applied to enhance the visibility of the viewed image seen on a standard PC Color Monitor.
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