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510(k) Data Aggregation

    K Number
    DEN130033
    Device Name
    COGNIVUE
    Manufacturer
    CEREBRAL ASSESSMENT SYSTEMS, INC
    Date Cleared
    2015-06-05

    (723 days)

    Product Code
    PKQ, PKO
    Regulation Number
    882.1470
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEREBRAL ASSESSMENT SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cognivue testing is indicated as an adjunctive tool for evaluating perceptual and memory function in individuals aged 55-95 years old.
    Device Description
    Cognivue provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose of identifying a potential decline in cognitive function relative to baseline test performance of other age-normal adults, referring those adults for further testing where warranted, and monitoring changes in cognitive function over time. Cognivue presents a series of visual stimuli and a wedge-shaped cursor. The display presents stimuli at varying signal strengths with a moving domain-specific target. The patient identifies the target location by moving the cursor using the rotatory mouse manipulandum. The patient is scored based on the timing and accuracy of the responses. Repeated trials of varying difficulty characterize the subject's performance in each of the tested functional domains.
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