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510(k) Data Aggregation

    K Number
    K251366
    Device Name
    EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
    Manufacturer
    Nihon Kohden Corporation
    Date Cleared
    2025-10-09

    (161 days)

    Product Code
    OLT,GWE,GWQ,OLV
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K080546,K101691
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EEG-1260A Neurofax System
    The EEG-1260A series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in sleep disorders, epilepsies and other related disorders as an aid in diagnosis. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic, or nursing home or outside of a medical facility under direct supervision of a medical professional.

    JE-940A EEG Amplifier Unit
    The EEG amplifier unit is intended to acquire and record the EEG and other biological signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform) of a patient, and transmit the measurement data to the electroencephalograph. The transmitted measurement data is displayed on the electroencephalograph screen and provides information to evaluate the functional state of the brain, brain-related diseases and disorders, and sleep disorders.

    The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel.

    The device is available for use on any patient as determined by qualified medical personnel.

    LS-940A Photic Light
    The photic stimulator is a light source for photic stimulation to confirm the responsiveness of EEG to photic stimulation during EEG tests and to test visual evoked potentials.

    The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel.

    The device is available for use on any patient as determined by qualified medical personnel.

    Device Description

    The EEG-1260A Neurofax is an electroencephalograph system specifically designed for use in healthcare facilities. This device is designed to measure and display the patient's electroencephalogram (EEG) and polysomnography (PSG) signals, providing information and analysis of brain electrical activity.

    The JE-940A EEG amplifier unit is a new amplifier unit and is an input unit of the EEG-1260A. The JE-940A Amplifier unit acquires and measures EEG and other polysomnography signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, and pulse waveforms) associated with EEG/PSG testing, and transmits the acquired data to the EEG-1260A Neurofax. The JE940A operates on AC power or on battery power for mobile EEG measurements. The JE-940A offers an option to connect with the JE-944A Mini electrode junction box, which enhances the operational efficiency and mobility in EEG measurements.

    The LS-940A Photic stimulator is a device which provides visual stimuli in the form of flashing light and is used to assess a patient's EEG responses to light stimulation. The parameters for flashing the light signal are controlled by the EEG-1260A Neurofax.

    AI/ML Overview

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