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510(k) Data Aggregation

    K Number
    K120104
    Device Name
    VISIONSEARCH 1
    Manufacturer
    VISIONSEARCH PTY LTD
    Date Cleared
    2012-05-21

    (129 days)

    Product Code
    GWE
    Regulation Number
    882.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONSEARCH PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrophysiological Test Unit for quantifying the response to visual stimulation by measuring the Visual Evoked Potential.
    Device Description
    The Visionsearch1 System consists of specialist software and the supporting computer and peripherals. The System displays multifocal visual patterns to evoke response in the retina which are transmitted to the visual cortex. The System then detects responses in the visual cortex using specific, validated third party EEG electrodes and biological amplifier. After analyzing the EEG, the System displays the electrical response from each segment of the retina. It also allows the user to compare the response time between eyes and compare an individual's measurements to those from a set of data that the user has compiled as reference.
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