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510(k) Data Aggregation

    K Number
    K030737
    Device Name
    OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
    Manufacturer
    CTF SYSTEMS (2001), INC.
    Date Cleared
    2003-10-10

    (214 days)

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

    CTF SYSTEMS (2001), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omega Whole-Cortex MEG System non-invasively measures The magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. 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.
    Device Description
    The Omega Whole-Cortex MEG Systems integrate up to 307 dc-SQUID axial gradiometers with workstation computers and data acquisition software in order to measure the magnetic signals generated by intercellular dendritic currents. These detectors positioned in a helmet shaped array gives the user the ability to record electrical activity of the entire surface of the brain simultaneously without having to move the position of the probe.
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