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510(k) Data Aggregation

    K Number
    K032324
    Device Name
    ECHOENCODER
    Date Cleared
    2003-10-02

    (66 days)

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

    ICARDIOGRAM, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be used by health care professionals in the field of echocardiography. The device is capable of transferring ultrasound images over long distances as digital files. It is used to transmit echocardiograms over the Internet for the purpose of interpretation of echocardiograms at a remote location. It is anticipated that it will be used when echocardiograms must be performed in a location where no interpreting cardiologist is present, and will facilitate prompt interpretation of echocardiograms. It should be particularly useful in rural areas of the United States.
    Device Description
    Echoencoder is a combined software-hardware system that is composed of three parts: 1) a system for conversion of analog echocardiographic video to a Quicktime movie file format, and subsequent automated transfer of that file to an Internet server; 2) a system for conversion of digital echocardiographic video to a Quicktime movie file format, and subsequent automated transfer of that file to an Internet server; and 3) an optional Server based database system for tracking of interpretations of the video so obtained. The system for analog video conversion is composed of a Macintosh computer equipped with the echoencoder software, and a video cassette recording device equipped with a video digitizer. The cassette recorder is interfaced with the computer via a firewire cable. The operator inserts a video cassette into the video cassette recorder, and uses the software program to convert the video into a Quicktime movie, perform MPEG-4 based video compression to compress the file by approximately 50:1, and transfer the file to a server where it can be subsequently reviewed by a Cardiologist. The system for digital video conversion is also composed of a Macintosh computer equipped with the echoencoder software, and is interfaced with a health care provider's network server. The operator selects the file to be converted, generally in DICOM format, and the software subsequently converts the video into a Quicktime movie, performs MPEG-4 based video compression to compress the file by approximately 25:1, and transfers the file to a server where it can be subsequently reviewed by a Cardiologist. The server based database product is, by the customer's option, interfaced with the above described Echoencoder system. This system that is based on the software product Filemaker Pro, and allows for electronic report generation and review.
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