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510(k) Data Aggregation

    K Number
    K971776
    Device Name
    ECHOVACS
    Manufacturer
    Date Cleared
    1997-07-14

    (62 days)

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

    VMI TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EchoVACS™ is indicated for the capture, archiving, retrieval and display of echocardiography images. It permits annotation of images as well as recording and analysis of workload statistics. It also permits report generation from a comprehensive internal lexicon of anatomic and diagnostic terms covering adult, pediatric and fetal echocardiography.
    Device Description
    EchoVACS™ is an all-digital networked system that is intended to give the echocardiography department a solution for the capture, storage, retrieval and reporting of full-length echocardiograms. EchoVACS™ consists of three modules: - Capture station this is connected to the ultrasound machine and . acquires the patient's echo exam. The images are compressed using MPEG (Moving Pictures Expert Group) which is an ISO standard (ISO/IEC 11172). Once captured, the exam is available to any station on the network. - Review station this is connected to the network and is used to both view . echo exams and to generate the physician's report. - Database server this supports the Capture and Review stations by . providing centralized functionality such as the storage of patient demographics.
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