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510(k) Data Aggregation

    K Number
    K053463
    Device Name
    AIM ACCURACY IN MARKING SYSTEM
    Manufacturer
    Date Cleared
    2006-03-07

    (84 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    GEORGENE AUSTRIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Accuracy In Marking® is a marking device used in conjunction with a transducer during vascular mapping. The device allows the user to mark a vascular area immediately when it is identified during mapping process. The guide path underneath the transducer allows the user to identify the target vessel prior to marking. The product is supplied non-sterile and is intended for single use only.
    Device Description
    The marking device is enables the sonographer to mark the "targeted" vessel during vascular mapping. The shadow guide is an adhesive "film" adhered directly underneath the footing of the transducer used as guide on identifying the vessel. The marking device and the "shadow guide" are attached to a transducer using a non-latex adhesive. The device shall be sold non-sterile for single use only. This device is compatible with FDA approved linear and curved linear ultrasonic transducers in the frequency of 4MHz to 12MHz.
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