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510(k) Data Aggregation

    K Number
    K212936
    Device Name
    Vision Monitor- MonCvONE
    Manufacturer
    Metrovision
    Date Cleared
    2022-11-21

    (432 days)

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

    Metrovision

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vision Monitor MonCvONE system is a non-invasive medical device used to generate photic stimulations and to register the responses including electrical responses generated by the retina and the visual nervous system in addition to psychophysical and pupillary responses. It displays digitized electroretinogram (ERG), visual evoked potential (VEP), sensory electro-oculogram (EOG), light and dark adapted perimetry thresholds, dark adaptometry, full field stimulus threshold (FST), photo aversion thresholds (PAT), pupillometry as curves, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.
    Device Description
    Photopic stimuli are presented to the patient on a hemispherical cupola. Various modes are available for preferential stimulation of different visual functions. Electrophysiological data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device). Psychophysical responses are recorded with a press button and pupillometry responses recorded with an eye tracker. 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 operator. Once the resulting individual responses 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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    K Number
    K211643
    Device Name
    Vision Monitor - MonpackONE
    Manufacturer
    Metrovision
    Date Cleared
    2021-07-26

    (60 days)

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

    Metrovision

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vision Monitor MonPackONE 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.
    Device Description
    Photopic stimuli are presented to the patient on a LCD-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 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 topoqraphical representation.
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