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510(k) Data Aggregation

    K Number
    K050376
    Device Name
    PROWIN
    Manufacturer
    MEDICAL TECHNOLOGIES INTERNATIONAL, INC.
    Date Cleared
    2005-04-07

    (52 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL TECHNOLOGIES INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prowin™ software program is a Windows-based application used on a personal computer intended for viewing carotid ultrasound images and measuring arterial wall thickness. It is specifically indicated for the measurement of carotid artery far and near wall intima-media thickness (IMT) from images obtained from an ultrasound system. A physician may use this information in conjunction with other medical data in the assessment of a patient's cardiovascular risk.
    Device Description
    Prowin™ is a software program designed to measure carotid artery intimamedia thickness from ultrasound images. Prowin™ operates on a stand-alone personal computer running a Microsoft Windows™ operating system. Carotid artery images from any ultrasound machine are transferred to the computer running Prowin™ by way of any media. Following the transfer of images, Prowin™ uses proprietary, patent-pending algorithms to measure intima-media thickness (IMT) of the near and far walls of the carotid artery. The Prowin™ software also has the capability to generate a report indicating the IMT value.
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