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510(k) Data Aggregation

    K Number
    K242198
    Device Name
    ICS Dizcovery (1091)
    Manufacturer
    Natus Medical Denmark Aps
    Date Cleared
    2025-02-14

    (203 days)

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

    Natus Medical Denmark Aps

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ICS Dizcovery is used in the assessment of the vestibular-ocularreflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements. The 1091 ICS Dizcovery is used in the assessment of patients with complaints of a vestibular nature such as dizziness, disequilibrium, and vertigo. The ICS Dizcovery type 1091 does not treat or diagnose the patient; the diagnosis is determined by the credentialed physician. ICS Dizcovery system is intended to be used by qualified medical personnel. Typical device users are Neurologists, Ears, Nose, and Throat specialists (ENTs), Audiologists, Physical Therapists, and Technicians supervised by one of the four mentioned typical users. Professionals with knowledge of diagnosing balance disorders. Users are assumed to have prior knowledge of the medical and scientific facts underlying the procedures offered by the ICS Dizcovery system. The intended patient population are children in the age of 10 to 18 and adults in age range from 18 to 99 years with a complaint of dizziness, balance disorder, or vestibular disease.
    Device Description
    The ICS Dizcovery device is a portable video-oculography (VOG) device. The device shall be indicated for videonystagmography for the assessment of patients with complaints of dizziness, disequilibrium, and vertigo. It provides an assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements. The ICS Dizcovery is a wearable measurement system in the form of goggles, with built-in cameras and a motion sensor that simultaneously track eye- and head-movement, respectively. The goggles have two cameras that collect the eye movement video. The goggle device is connected to a PC with Otosuite Vestibular PC software (through a USB cable). The Otosuite Vestibular software functions by processing the binocular camera data collection. The collection of eye movement data is analysed to eye movement in respect to various stimuli throughout testing. The ICS Dizcovery system is made up of the following components: - A pair of binocular video goggles for testing, controlled through the Otosuite Vestibular PC software - Otosuite Vestibular PC software for controlling tests, displaying test data for the various ● tests, reviewing, and printing test results, as well as and managing patients and patient data, users, and test devices. - A set of Shadeshift® Vision Denied panels; these panels deny the patients vision throughout ● testing whilst allowing the clinician to continue tracking the eyes in darkness. Vision denied testing is needed throughout the test workflow. - . A set of LCD panels; these automatically shift between dark states to facilitate a userfriendly approach to Skew Deviation testing. This removes the need for manually denying vision of each eye separately with the use of a hand or a paddle. - A face cushion which inserts into the goggle frame to promote comfort whilst wearing and allow a better fit to face.
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