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510(k) Data Aggregation

    K Number
    K101763
    Device Name
    DIOPSYS NOVA VEP VISION TESTING SYSTEM
    Manufacturer
    DIOPSYS INC.
    Date Cleared
    2011-05-09

    (320 days)

    Product Code
    GWE
    Regulation Number
    882.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIOPSYS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NOVA is an electrophysiological device that generates photic stimuli, and records, processes and analyzes the resultant visual evoked potential (VEP) signals to provide information about the visual system structural and neural abnormalities.
    Device Description
    Checkerboard, Horizontal grating, Vertical grating, Sinusoidal grating, Flash, monochromatic pattern onset or color pattern onset Contrast Photic stimuli are presented to the patient on a calibrated computer monitor at various numbers of elements in separately stimulated fields. The fields are varied in spatial size over a number of cycles. The fields are also phase reversed at different temporal frequencies. The signals are analyzed by the software algorithm for spatial/temporal filtering and artifact rejection. Data may be presented in numerical and graphical form. The device also utilizes attention grabbing features specifically for children or non attentive adults. In particular, a picture is presented prior to the onset of the VEP pattern stimulus. During the picture presentation no data is collected. Age appropriate music is also available to patient as well. The music is only intended as an attention facilitator. From a hardware standpoint the NOVA system is identical to that of the Enfant, ® which was cleared under K043491. The only difference between the two devices is the software.
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    K Number
    K043491
    Device Name
    ENFANTTM
    Manufacturer
    DIOPSYS INC.
    Date Cleared
    2005-03-16

    (89 days)

    Product Code
    GWE, GWL, GWQ
    Regulation Number
    882.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIOPSYS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Enfant is a non-invasive medical device to screen, without dilation or sedation, for visual disorders in infants and pre-school children. The system uses Visual Evoked potentials to provide information about the visual pathway function and about optical or neural abnormalities related to vision.
    Device Description
    Horizontal Contrast Photopic stimuli are presented to the patient on a computer monitor at various numbers of elements in separately stimulated fields. The fields are varied in spatial size over a number of cycles. The signals are analyzed by the software using algorithms for spatial filtering and artifact rejection. Data may be presented in number form and on a graph. The device also adds some attention features specifically for children. In particular, a cartoon is presented prior to the VEP pattern. During the Cartoon presentation no data is collected. Age appropriate music is also presented to patient as well. The music is only intended as an attention facilitator.
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