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510(k) Data Aggregation

    K Number
    K101391
    Device Name
    SCANDIA-45 GAMMA CAMERA SYSTEM
    Date Cleared
    2010-08-04

    (78 days)

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

    SCANDIA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use in the acquisition, processing, display, and analysis of planar images of the thyroid and other small organs.
    Device Description
    The Scandia-45 is a high resolution, SFOV digital gamma camera for thyroid and small organs imaging. The Scandia-45, is made up of a single, small-field detector assembled with high optical and mechanical quality. The systems has 45 high quantum efficiency photomultipliers characterized by improved energy resolution, magnetic shielding and long-term stability and utilizes a compact, highly integrated, one board, easily serviceable construction without tuning potentiometers. The acquisition console has full-digital electronics, including fast PCI bus acquisition interface. The system also has a light-weight, easilyadjustable gantry and light, easily-exchangeable microcast collimators.
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