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510(k) Data Aggregation

    K Number
    K030223
    Device Name
    SONOCALC
    Manufacturer
    SONOMETRIC HEALTH, LLC
    Date Cleared
    2003-02-06

    (15 days)

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

    SONOMETRIC HEALTH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SonoCalc software is a Windows-based application program used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from images obtained from ultrasound systems.
    Device Description
    SonoCalc is a software package that runs on a stand-alone computer running a Microsoft Windows™ operating system. There is no dedicated medical equipment required for operation of this software application except for an ultrasound machine that is the source of images of the carotid artery. These images are digitally transferred from the ultrasound machine to the computer containing the software application. SonoCalc then uses proprietary techniques and algorithms to measure the Intima-Media Thickness (IMT) of either or both of the near or far wall(s) of the carotid artery. SonoCalc can generate a report indicating what the patient's IMT value is. This information is used adjunctively with other medical data by a physician to help assess the cardiovascular health of a patient. SonoCalc also is capable of storing patient measurement values on the hard disk along with the images for future reference.
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