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510(k) Data Aggregation

    K Number
    K221471
    Device Name
    E3 and Profile
    Manufacturer
    Diagnosys LLC
    Date Cleared
    2022-11-22

    (186 days)

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

    Diagnosys LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The E3 and Profile system is an electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals, for use with patients who are experiencing visual system abnormalities.
    Device Description
    Photopic stimuli are presented to the patient using LEDs or a monitor, using 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 lavers. Data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device). During the period of time that the system is acquiring 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 acquired, 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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