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510(k) Data Aggregation

    K Number
    K982612
    Device Name
    ESP7 VENOUS IMAGE
    Manufacturer
    Date Cleared
    1998-12-14

    (140 days)

    Product Code
    Regulation Number
    880.6970
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRONMASTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ESP7 Venous Imager is a non-invasive electronic visual aid device for the purpose of viewing of the human superficial venous vasculature. Indications for use: 1) viewing the superficial venous vasculature as a visual aid in taking blood or inserting an I.V.
    Device Description
    The "ESP7 Venous Image" is designed for the same purpose, to locate veins which are otherwise not visible to the naked eye. It uses a similar technology in that it uses a standard Video Camera and television monitor mounted on a roll around height and angle adjustable metal stand. The ESP7 Venous Image, however, uses an Infrared filter placed between the camera lens and the CCD to eliminate visible light from entering the camera but allowing infrared and ultra violet light to pass through to the monitor. An on board light source broadcasts a low intensity light beam on the subject. The light source is a common household incandescent 50 watt light bulb that illuminates from a wave length of 350 to 900 nanometers. The ultra violet in the below 450 range is absorbed by the melanin in the epidermis forming a translucent window for the infra red to pass through the skin and differentiate the blue or carbon dioxide carrying venous vessels from the other objects in view.
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