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510(k) Data Aggregation

    K Number
    K152727
    Device Name
    ISEN-Goggles
    Date Cleared
    2016-04-26

    (217 days)

    Product Code
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    **ISEN TECH **& TRADING COMPANY, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ISEN-Goggles are used to record and visually display movements of the eyes including nystagmus.
    Device Description
    This device consists of patient eye goggles with an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USB port to facilitate transfer of data captured and stored in the device's SD-type memory. The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for nearsimultaneous viewing of the video images from both eyes on the attached LCD screen.
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