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510(k) Data Aggregation

    K Number
    K033266
    Device Name
    VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS
    Date Cleared
    2004-12-16

    (434 days)

    Product Code
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL IMAGING APPLICATIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    "Vascular Tools 5" software program has been developed to aid in quantitative analysis of longitudinal vascular ultrasound images, particularly to determine vascular diameter and intima-media thickness, as well as their changes as depicted in brachial and carotid arterial ultrasound images.
    Device Description
    "Vascular Tools 5" quantification software system is a state-of-the-art product for computer-aided assessment of vascular diameter, intima-media thickness derived from existing ultrasound images. Based on computer-aided detection of vessel wall borders within a region of interest of a single longitudinal ultrasound image or a sequence of longitudinal ultrasound images, vascular diameter and/or IMT are reported for each ultrasound image frame or a user-defined subset of image frames. "Vascular Tools 5" is a proprietary software program for vascular ultrasound image quantification designed for installation on an IBM-PC-compatible personal computer and use with Windows 2000 r XP operating platform. It provides tools for display, selection, evaluation, and storage of multiple loops of vascular ultrasound image data. Furthermore, "Vascular Tools 5" facilitate impge on namprt of complete studies in "Vascular Tools 5" format, and the export of results into general spread sheets, databases, or in ASCII formats for further statistical analysis of study results by the users,
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