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510(k) Data Aggregation

    K Number
    K232688
    Device Name
    NQ TMS for MDD (NQv1-MU-01)
    Manufacturer
    NeuroQore, Inc.
    Date Cleared
    2023-12-29

    (119 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeuroQore, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NQ TMS for MDD is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
    Device Description
    The NeuroQoreTMS System (NQ TMS for MDD) enables direct non-invasive activation of brain structures. TMS is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain the induced field is above a certain threshold, and is directed in an appropriate orientation relative to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure. The NeuroQoreTMS System is composed of the following main components: · TMS Stimulator and Cooling Unit · Treatment Coil (Applicator) (Figure-of-eight) · Coil Arm (Applicator Arm) · Treatment Cap
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