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510(k) Data Aggregation

    K Number
    K161328
    Device Name
    Cantab Mobile
    Manufacturer
    CAMBRIDGE COGNITION LTD., US AGENT: CLEMENTI ASSOCIATES LTD.
    Date Cleared
    2017-01-13

    (246 days)

    Product Code
    PKQ
    Regulation Number
    882.1470
    Why did this record match?
    Product Code :

    PKQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CANTAB Mobile is intended to be used as an adjunctive tool to assess memory by testing visuospatial associative learning in patients aged 50 to 90 years.
    Device Description
    Not Found
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    K Number
    K150154
    Device Name
    ANAM Test System: Military Battery
    Manufacturer
    Vista LifeSciences, Inc.
    Date Cleared
    2015-08-28

    (217 days)

    Product Code
    PKQ
    Regulation Number
    882.1470
    Why did this record match?
    Product Code :

    PKQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANAM Test System: Military Battery provides clinicians with objective measurements of cognitive performance in military populations ages 18 to 65 years, to aid in the assessment of an individual's level of cognitive functioning. The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.
    Device Description
    ANAM Test System: Military Battery is a software only device that provides clinicians with objective measurements of cognitive performance in military populations, to aid in the assessment of an individual's level of cognitive function. The software is downloaded from the Vista LifeSciences website and is for use on a Dell Latitude E6440 Laptop. The laptop is not provided as part of the device, but is purchased separately by the user. Each ANAM battery consists of a collection of pre-selected modules that are administered in a sequential manner.
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    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?
    Product Code :

    PKQ

    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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