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510(k) Data Aggregation

    K Number
    K250094
    Device Name
    Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)
    Manufacturer
    Neuralynx, Inc.
    Date Cleared
    2025-04-14

    (90 days)

    Product Code
    GYC
    Regulation Number
    882.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neuralynx, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATLAS Stim Headbox is a low power, constant current or voltage mode, bi-phasic stimulator intended for cortical or intracranial stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes. The ATLAS Stim Headbox itself is an accessory to the ATLAS Neurophysiology System and ATLAS STIM Headbox software. The stimulation parameters, the electrodes selection and the activation of the stimulation current are all set-up and controlled from these devices. The ATLAS Stim Headbox can operate only when so connected and with the Pegasus and ATLAS Stim Headbox software; it cannot serve as a stand-alone stimulator.
    Device Description
    The ATLAS Stim Headbox (ASHB) is a clinical headbox that allows 3rd party Macro electrode contact electrode arrays (ECoG, depth electrodes, grid array, strip array, etc.) to interface with the Neuralynx ATLAS Neurophysiology System, previously cleared in 510(k) K110967, which includes the Pegasus Software. The ATLAS Stim Headbox is an accessory to the ATLAS Neurophysiology System (formerly known as SpikeTrax in K110967). The ATLAS Stim Headbox hardware consists of an encased amplifier and embedded firmware for generation and delivery of stimulation energy. The ATLAS Stim Headbox can deliver electrical stimulation current under the control of the associated ATLAS Stim Headbox Software which interfaces via a fiber optic ethernet communications connection.
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