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510(k) Data Aggregation

    K Number
    K020643
    Device Name
    EZ-SCOPE AN & EZ-SCOPE AN LITE
    Manufacturer
    HEALTH POLICY RESORTERS GROUP, LLC
    Date Cleared
    2002-05-28

    (90 days)

    Product Code
    IYX
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTH POLICY RESORTERS GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anzai eZ-Scope AN Portable Gamma Camera is indicated for use to image the distribution of radionuclides in the human body using planar imaging techniques. The eZ-Scope may be used on pathological specimens if a protective sheath is used.
    Device Description
    The Anzai eZ-Scope AN Portable Gamma Camera is a new and innovative portable gamma camera. The camera utilizes a solid state detector, rather than a scintilator, to detect gamma rays. The cadmium-zinc-tellurium detector allows sharp energy discrimination and spatial resolution. The detector array is made from pixelized cadmium-zinc-telluride (CZT) crystals, with each of the 256 pixels having dimensions of 2 x 2 mm. The system will be available in two configurations, eZ-Scope AN and eZ-Scope Life. These differ primarily in the computer, the former model using a desktop computer and the latter a laptop. In the desktop version, the computer is mounted on a cart, while the laptop version does not have a cart.
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