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510(k) Data Aggregation

    K Number
    K052571
    Device Name
    MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
    Manufacturer
    NEUROGNOSTICS, INC.
    Date Cleared
    2005-10-17

    (28 days)

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

    NEUROGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in functional Magnetic Resonance Imaging (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. fDAD presents a stimulus to the patient and collects the patient's responses from a button device. Execution of specific cognitional tasks by the patient (in response) generates functional data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD. The fDAD-PT (fDAD Personal Trainer) is used to train the use of the four button response device and to ensure their understanding and successful execution of the specific task. A short activation task is presented on the fDAD-PT control station to ensure the patient is aware of the nature of the response to be provided.
    Device Description
    The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in functional Magnetic Resonance Imaging (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. fDAD presents a stimulus to the patient and collects the patient's responses from a button device. Execution of specific cognitional tasks by the patient (in response) generates functional data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD. The fDAD-PT (fDAD Personal Trainer) is used to train the use of the four button response device and to ensure their understanding and successful execution of the specific task.
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    K Number
    K043290
    Device Name
    MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0
    Manufacturer
    NEUROGNOSTICS, INC.
    Date Cleared
    2005-01-28

    (60 days)

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

    NEUROGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. fDAD presents a stimulus to the patient and collects the patient's responses from a button (response) device. Execution of specific cognitive or motor activation tasks by the patient in response to a set of stimuli creates the necessary behavioral data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD. The fDAD-PT (fDAD Personal Trainer) is used to train the patient in the use of the four button response device and to ensure their understanding and ability to perform the specific task. A short activation task is presented on the fDAD-PT control station and the patient is allowed to become familiar with the nature of the activation task and the nature of the response to be provided.
    Device Description
    The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. fDAD presents a stimulus to the patient and collects the patient's responses from a button (response) device. Execution of specific cognitive or motor activation tasks by the patient in response to a set of stimuli creates the necessary behavioral data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD. The fDAD-PT (fDAD Personal Trainer) is used to train the patient in the use of the four button response device and to ensure their understanding and ability to perform the specific task. A short activation task is presented on the fDAD-PT control station and the patient is allowed to become familiar with the nature of the activation task and the nature of the response to be provided.
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