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510(k) Data Aggregation

    K Number
    K111142
    Device Name
    ECHOSOFT(TM)
    Manufacturer
    Date Cleared
    2012-09-21

    (518 days)

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

    ECHOMETRIX LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EchoSoft™ is a software calculation package that is used with diagnostic ultrasound images to provide mechanical information about tendon-like tissues of interest that may be used by a physician, along with other medical data, to assist in clinical diagnosis. The software is intended to be used by trained professionals only.
    Device Description
    The Echometrix, LLC software, EchoSoft, is an image processing algorithm that, when used with diagnostic ultrasound images, provides qualitative information about the mechanical characteristics of the deforming material by tracking motion, deformation, and ultrasonic echo magnitude change within a given region. This technology can be used by a physician to gather information about the mechanical and functional properties of soft tissues which, in conjunction with standard medical data, can be used to assist in clinical diagnosis.
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