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510(k) Data Aggregation

    K Number
    K051745
    Device Name
    ECHOSYSTEM
    Manufacturer
    Date Cleared
    2005-07-14

    (15 days)

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

    MEDSTRAT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medstrat echoeSYSTEM™ is intended to enable the communication, storage, viewing and manipulation of diagnostic medical images and data. The echoeSYSTEM™ can show images on workstations locally and/or across computer networks at widely distributed locations. The echoeSYSTEM™ software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical echoeSYSTEM™ users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and other authorized medical professionals. It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.
    Device Description
    ECHOES™ is a client-server software system designed to allow viewing access to medical images on a personal computer by authorized medical professionals. This product is designed to function with off-the-shelf hardware and software products including standard communications products. It does not require specialized, or nonstandard, devices of any type. Image acquisition is via the industry standard DICOM 3.0 protocol allowing the images to be produced from the digital data originated by the imaging modality. The software will run on standard off-the-shelf hardware and system configurations,
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