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510(k) Data Aggregation

    K Number
    K040686
    Device Name
    M'ATH STD
    Manufacturer
    INTELLIGENCE IN MEDICAL TECHNOLOGIES
    Date Cleared
    2004-07-30

    (136 days)

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

    INTELLIGENCE IN MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    M'Ath® software is a Windows based application program running on a personal computer that is intended to aid the physician in the organisation of patient data relating to the ultrasound images or video acquired during vascular examination by sonography, and including patient characteristics. Additionally the software allows making measurements to determine the intima media thickness of the carotid artery from the accurate image and store them with the patient file.
    Device Description
    M'Ath®Std is a software running on a stand alone computer under Microsoft Windows operating system. Images are captured from any ultrasound device. Proprietary algorithms are used to measure Intima Media Thickness ( IMT).Storage of patient measurements values can be performed during the examination. These measurements help to detect early atherosclerosis in the carotid vascular bed.
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