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510(k) Data Aggregation

    K Number
    K203082
    Device Name
    Insight Infrared Video Goggles
    Manufacturer
    Vestibular First
    Date Cleared
    2020-11-12

    (30 days)

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

    Vestibular First

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insight Infrared Video Goggles are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.
    Device Description
    The Insight Infrared Video Goggles system displays and records eye movements on a computer from cameras mounted to goggles worn by a patient The eye movements called nystagmus are part of the body's balance system and can be analyzed by a trained clinician to provide objective information during a vestibular exam. The goggles are designed to block all external light from the patient's eyes so they are unable to fixate on anything in their visual field. This is an important performance characteristic of the googles since the eyes can suppress abnormal nystagmus when not occluded. The goggles have a durable plastic shell that houses two (2) cameras, infrared LED lights, two (2) switch-driven visible lights, and a face cushion. The goggles connect to the computer with a 4 m USB cable and are designed to be worn by the patient for 10 to 15 minutes on average in various body positions as directed by the clinician.
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