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510(k) Data Aggregation

    K Number
    K053062
    Device Name
    CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2
    Manufacturer
    CARDIARC LTD.
    Date Cleared
    2006-01-06

    (67 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIARC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CARDIARC SPECT IMAGING DEVICE and its predicate device is intended to be used for production of single photon emission computed tomography clinical images of the heart in nuclear medicine applications. The CARDIARC SPECT IMAGING DEVICE is indicated for use to produce images from the distribution of radioisotopes within the thorax, which are then interpreted by healthcare professionals to assess various anatomical structures and functions (e.g., blood flow to the heart).
    Device Description
    The CARDIARC SPECT IMAGING DEVICE consists of an integrated patient chair which adjusts in height but does not rotate, an arc with no external moving parts, which is constructed of an internal rotating slot collimator, horizontal lead vanes separated by foam spacers, cadmium zinc telluride (CZT) detectors, and electronic components, a power supply, cooling system, and hardware and software components.
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