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510(k) Data Aggregation

    K Number
    K093336
    Device Name
    INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM
    Date Cleared
    2010-03-05

    (130 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL NUMERICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Integrated Stimulus Delivery System (ISDS), both Optimum and Premium models, is indicated for use by trained medical professionals to aid in the performance of functional Magnetic Resonance Imaging (fMRI) examinations based on Blood Oxygen Level Dependent (BOLD) contrast. The ISDS works with GE 1.5T and 3.0T Magnetic Resonance (MR) scanners with BrainWave™ software installed. The ISDS presents to the patient specific visual and audio stimuli with predetermined order and timing patterns and collects keypad responses; all ISDS functions are synchronized with the ongoing patient MR imaging examination.
    Device Description
    For a patient undergoing a functional MR imaging examination the ISDS hardware components present visual and auditory stimuli to a patient and collect responses from that patient while the patient is in the bore of the MR scanner. Hardware components interface the ISDS computer system to the MR scanner in order to synchronize operation of the ISDS with the MR imaging procedure. The stimuli delivery (type of stimuli, stimuli presentation order, timing of stimuli presentation, etc.) is controlled by a proprietary software application.
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