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510(k) Data Aggregation

    K Number
    K143468
    Device Name
    QbCheck
    Manufacturer
    QBTECH AB
    Date Cleared
    2016-03-22

    (474 days)

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

    QBTECH AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QbCheck provides health care professionals with objective measurements of hyperactivity, and inattention to aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD. Q6Check results should be interpreted only by qualified health care professionals.
    Device Description
    QbCheck is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity of an individual to pay attention to visual stimuli and inhibit impulses. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD); impaired attention, hyperactivity and impulsivity. QbCheck provides an accurate and reproducible measure of an individual'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 QbCheck is a computer-assisted attention and impulse control task and simultaneous recording of activity. QbCheck is an online solution and no extra hardware is needed as the test is performed on the user's own computer. For the activity tracking analysis QbCheck uses the built in camera in the user's laptop or a separate web camera on the user's desktop computer. QbCheck consists of the following; ● QbCheck client and server software . Online test with instructions, a continuous performance task (CPT) and motion measurement technology through web camera. - Access to a remote server which generates test results . - Secure access to a result report - User manual ● - Technical manual - QbCheck Behavior Observation Form .
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    K Number
    K133382
    Device Name
    QB TEST
    Manufacturer
    QBTECH AB
    Date Cleared
    2014-03-24

    (140 days)

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

    QBTECH AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QbTest provides clinicans with objective measurements of hyperactivity, and inatention to aid in the clinical assessment of ADHD (Attention Deficit Hyperactivity Disorder) an interentions in patients with ADHD. QbTest results should be interpreted only by qualified professionals.
    Device Description
    QbTest is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity of an individual to pay attention to visual stimuli and inhibit impulses. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD): impaired attention, hyperactivity and impulsivity. QbTest provides an accurate and reproducible measure of an individual'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 QbTest is a computer-assisted attention and impulse control task and simultaneous recording of activity using an infrared camera for motion measurements. The system consists of the following components: - · Client software - · Responder button (also referred to as responder unit) - · Infrared camera - · Reflective motion marker - · User manual - Technical manual - · Stimulus card - · Camera stand - · Measuring tape - · QbTest Behavior Rating Scale - · In addition, the user must have access to a remote server that generates test reports
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    K Number
    K122149
    Device Name
    QBTES
    Manufacturer
    QBTECH AB
    Date Cleared
    2012-10-17

    (90 days)

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

    QBTECH AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QbTest is indicated to be used to aid in the clinical assessment of ADHD. QbTest results should be interpreted by qualified health care professionals only. QbTest provides clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD. QbTest results should be interpreted only by qualified professionals.
    Device Description
    QbTest is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity for an individual to pay attention to visual stimuli and inhibit impulses. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD); impaired attention, hyperactivity and impulsivity. QbTest provides an accurate and reproducible measure of an individual'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 QbTest is a computer-assisted attention and impulse control task and simultaneous recording of activity using an infrared camera for motion measurements. The system consists of the following components: - Client software - Responder button (also referred to as responder unit) - Infrared camera - Reflective motion marker - User manual - Technical manual - Stimulus card - Camera stand - Measuring tape - QbTest Behaviour Rating Scale - In addition, the user must have access to a remote server that generates test reports
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    K Number
    K040894
    Device Name
    QBTEST
    Manufacturer
    QBTECH AB
    Date Cleared
    2004-06-22

    (77 days)

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

    QBTECH AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QbTest provides clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD. QbTest results should be interpreted only by qualified professionals.
    Device Description
    The QbTest is a 15 minute, non invasive test that has been developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli while inhibiting their loco motor activity and controlling their urge to respond impulsively. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD) impaired attention, hyperactivity and impulsivity. QbTest 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 QbTest is a computer-administered go/not-go vigilance response task combined with motion capture. The system consists of the following components; • Client PC software • Connection box • Responder button • Camera for motion measurement • Reflective marker • USB and serial cable
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