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510(k) Data Aggregation

    K Number
    K141865
    Device Name
    DANA
    Manufacturer
    ANTHROTRONIX, INC
    Date Cleared
    2014-10-15

    (97 days)

    Product Code
    LQD
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANTHROTRONIX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state. Factors that may affect the measurement of reaction time include, but are not limited to concussion, head injury, insomnia, post traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), memory impairment, delirium, prescription and non-prescription medication, some nutritional supplements, as well as a variety of psychological states (e.g. fatigue and stress). DANA also delivers and scores standardized psychological questionnaires. DANA results should be interpreted only by qualified professionals.
    Device Description
    DANA is a mobile application indicated to provide clinicians with objective measurements of reaction time (speed and accuracy) and standardized health assessments to aid in the assessment of an individual's medical or psychological state. DANA results should be interpreted only by qualified professionals. DANA was developed on a mobile platform to improve the access and availability of reaction time tests and standardized health assessments through (1) custom configuration of the system by clinicians based on their need and discretion; and (2) allowing for objective health assessments both in-clinic and out-of-clinic settings.
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