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510(k) Data Aggregation

    K Number
    K023525
    Device Name
    RETISCAN, RETIPORT
    Manufacturer
    ROLAND CONSULT
    Date Cleared
    2004-03-26

    (522 days)

    Product Code
    GWE
    Regulation Number
    882.1890
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    Applicant Name (Manufacturer) :

    ROLAND CONSULT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrophysiological Test Unit for quantifying the retinal response, measuring a parameter (VEP) related to retinal response
    Device Description
    Photopic stimuli are presented to the patient on an VGA-screen at a various number of elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanism and isolation of signal from different retinal layers. Data are required by up to 8 recording channels using conventional EEGelectrodes. During the period of time that the system is aquiring data (1-20 minutes), there is a real time display of the raw and processed data presented to the user. Once the resulting individual waveforms are aquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topographical representation.
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