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510(k) Data Aggregation

    K Number
    K051853
    Device Name
    CARDIOSTREAM SONOAIM
    Manufacturer
    Date Cleared
    2005-08-22

    (45 days)

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

    CARDIOSTREAM, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CardioStream SonoAim is intended for capturing, transporting, and reporting patient cardiac study data.
    Device Description
    The CardioStream SonoAim is a clinical assessment tool designed to automate the movement of clinical data through the clinical assessment process. The system is comprised of the following components: Data Harvester (DH) - Laptop (variations - desktop, pole-mounted LCD screens), Data Packager (DP) - Computer (tower), AIM Server - Archive and Image Manager - located at secure off-site data center. Data and images are captured in the clinical setting via an image capture device (DH), and a preliminary report is completed by the Sonographer. The preliminary report is immediately formatted (DP) and available on a secure webaccessed internet site. The physician with secure user name and password will then access/review the clinical images and preliminary report, and edit or add commentary as needed. The final report is then electronically signed and returned to the referring physician. The information is available on any web-accessible device.
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