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510(k) Data Aggregation

    K Number
    K020800
    Device Name
    OPTAX SYSTEM
    Manufacturer
    OPTAX SYSTEMS, INC.
    Date Cleared
    2002-06-10

    (90 days)

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

    OPTAX SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OPTAx System provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OPTAx results should be interpreted only by qualified professionals.
    Device Description
    OPTAx (Optical Tracking and Attention test) is a 15 minute non-invasive, office-based test that was developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli, while inhibiting their locomotor activity and controlling their impulsive responses. The three core symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) are : impaired inattention, hyperactivity, and impulsivity. OPTAx provides an accurate and reproducible measure of a child's capacity in each of these three domains by utilizing a consistent challenge paradigm, coupled with detailed real-time measurements of behavior and performance. The fundamental core of OPTAx is a computer-administered GO/NO-GO vigilance response task. The OPTAx System consists of the following components: - . IMac computer and peripherals (printer and adapters) - Pre-installed OPTAx software program ● - . Motion analysis camera and peripherals - Data analysis software on the OPTAx secure server .
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