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510(k) Data Aggregation

    K Number
    K973065
    Device Name
    REALVIEW TELEMEDICINE SYSTEM
    Manufacturer
    Date Cleared
    1997-11-13

    (87 days)

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

    VCOM SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RealView Telemedicine System is used for medical digital image capture, storage, retrieval, and transmission over telecommunications media. A physician would use our system to take images of a patient for a permanent record of their condition and also to send them to a colleague for referral purposes or a consultation. The condition.
    Device Description
    The system consists of hardware that attaches to a physician's examining equipment, video camera, Personal Computer (PC) containing a video capture card, sound card and modem, and running Windows 95® operating system and RealView™ Telemedicine Software and foot pedals for image capture.
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