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510(k) Data Aggregation

    K Number
    K223047
    Device Name
    NeuroSwift Pro
    Manufacturer
    Neurobit Technologies Co., Ltd.
    Date Cleared
    2023-06-29

    (273 days)

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

    Neurobit Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeuroSwift Pro is intended for Viewing and recording eye movements in support of identifying vestibular disorders.The system is to be used by trained healthcare personnel in an appropriate healthcare setting. This system provides no diagnosis and does not provide diagnostic recommendations. The target population is 12+ years of age.
    Device Description
    The NeuroSwift Pro is intended for viewing and recording eye movements in support of identifying vestibular disorders. The system is to be used by trained healthcare personnel in an appropriate healthcare setting. This system provides no diagnosis and does not provide diagnostic recommendations. NeuroSwift Pro. model NS01-2 contains goggles and software. The NeuroSwift Pro is a combination of hardware and software, designed to provide information for clinicians as a supplement in clinical decision-making by eye movements. The NeuroSwift Pro goggle is a see-through binocular video goggle with a pair of light reflectors and 3 metered, nylon braided USB cable connecting to the computer interface. Accompanying components include a stable and sturdy head strap, face cushion, and a lightweight eye cover. The hardware provides high-definition video recording capability. The NeuroSwift Pro software is a computer interface designed to record eye movement videos and simultaneously display the visual target(s) on the computer screen. The software provides vestibular test modes and calibration functions. Initially, the software instructs the users to follow calibration functions. Then, the examiner can observe spontaneous nystagmus using the eye cover. The examiner can perform oculomotor tests with the goggles, while the patient follows visual targets on the screen. During gaze tests, the patient will fixate on stationary white spots that are positioned at center, right, left, up and down. In saccade tests the patient is asked to stare at the target moving in horizontal, vertical, or mixed pattern. In pursuit tests the patient's ability to track a target that moves in a sinusoidal or triangular pattern across the screen. The optokinetic function provides a large moving checkerboard pattern on the screen. Patients can change in various body positions as directed by the clinician. The software measures the eye movement via slow phase velocity and measures the eye position shift and trace. The recorded video and test protocols are processed in the NeuroSwift Pro software. The NeuroSwift Pro generates the traces of eye movements, eye velocities, and analytical data, which allows the clinician to determine the response of the patient according to the test functions.
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