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510(k) Data Aggregation

    K Number
    K964803
    Device Name
    UNIVISION ECHOCARDIOLOGY SYSTEM
    Manufacturer
    NETWORK CONCEPTS, INC.
    Date Cleared
    1997-02-11

    (74 days)

    Product Code
    LMB
    Regulation Number
    892.2010
    Why did this record match?
    Applicant Name (Manufacturer) :

    NETWORK CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIVISION™ Echocardiology System is a network system intended to use digital technology to acquire images from an echocardiogaphy ultrasound system for viewing outside the exam room and long term storage and retrieval on digital media.
    Device Description
    UNIVISION™ Echocardiology System is a real-time network system that provides review of echocardiograms either inside or outside the hospital environment. The exams are then archived on optical disc media. The UNIVISION™ Echocardiology System is comprised of three major subsystems: the Image Acquisition Unit (IAU); the Workstation; and the Archive Subsystem.
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