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510(k) Data Aggregation

    K Number
    K971329
    Device Name
    CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
    Manufacturer
    CTF SYSTEMS, INC.
    Date Cleared
    1997-11-20

    (224 days)

    Product Code
    GWQ, OLY
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CTF SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTF Systems Inc. "Whole-Cortex MEG System" non-invasively measures the magnetoencephalographic (MEG) signals (and, now optionally, electroencephalographic EEG signals) produced by electrically active tissue of the brain. These signals are recorded by the data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. MEG locations may then be correlated with anatomical information of the brain. MEG is also used to non-invasively locate the visual, auditory, somatosensory, and motor cortex in the brain. * MEG is also used to non-invasively locate regions of epileptic activity within the brain. * The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning. *when routinely used in conjunction with evoked response averaging devices
    Device Description
    The CTF "Whole-Cortex MEG System" integrates up to 200 dc-SQUID axial gradiometer detectors, a patient bed, a magnetic shielded room, workstation computers and data acquisition software in order to measure the magnetic signals generated by the intracellular and dendritic currents. These detectors are positioned in a helmet shaped array which gives the user the ability to record signals from the entire surface of the brain simultaneously without having to move the position of the probe.
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