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    K Number
    K243243
    Device Name
    Delphi MCS Electrode Cap
    Manufacturer
    QuantalX Neuroscience, Ltd.
    Date Cleared
    2025-02-06

    (118 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    QuantalX Neuroscience, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Delphi MCS Electrode Cap is an EEG electrode set intended for routine clinical settings where rapid placement of large number of EEG electrodes is desired.
    Device Description
    The Delphi MCS Electrode Cap is made of elastic textile material, preserving the shape and size. The cap provides the exact position of the electrodes on the head without the need for additional measurements and adjustments. Large holes are provided for ventilation and access to the electrodes and patient's skin. The cap is fixed to the head with a chinstrap. The Cap is available in the following sizes: XL 60-66cm, XL/L 57-63cm, L 54-60cm, L/M 51-57cm, M 48-54cm. The textile caps sizes are identifiable by the color material or seam and marking according to international system 10-20. The Ag/AgCl electrodes are designed to provide minimal polarization and long-term stability of the signal. The conductive surface of the electrodes which is housed inside the electrode base does not have direct skin contact; an electrically conductive substance (hydrogel) is used inside the electrode base for improved conductivity. Delphi Cap electrodes are thin cup Ag/AgCl sintered electrode for EEG recording. The electrodes are designed for maximum comfort while the patient in a supine position. The design of this electrode is suitable for conducting combined TMS-EEG studies. The Ag/AgCl sintered electrode material guarantees minimum polarization and long-term signal stability, as well as an increased electrode life.
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    K Number
    K242345
    Device Name
    Delphi Stimulator
    Manufacturer
    QuantalX Neuroscience
    Date Cleared
    2024-11-05

    (90 days)

    Product Code
    GWF, CLE
    Regulation Number
    882.1870
    Why did this record match?
    Applicant Name (Manufacturer) :

    QuantalX Neuroscience

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delphi Stimulator is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
    Device Description
    Delphi stimulator is a Magnetic stimulator used for Magnetic stimulation of peripheral nerves for diagnostic purposes. Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation. The Delphi stimulator is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The stimulator consists of power electronics to generate the magnetic field in the Magnetic Coil. It is controlled via a user interface installed on a PC workstation connected to the stimulator. enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 3 pulses per second (pps).
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