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510(k) Data Aggregation

    K Number
    K150688
    Device Name
    IdentEvent
    Manufacturer
    OPTIMA NEUROSCIENCE, INC.
    Date Cleared
    2015-11-05

    (233 days)

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

    OPTIMA NEUROSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IdentEvent® is a software-only product with an algorithm intended to analyze previously acquired, adult (≥18 years) scalp EEG signals and mark events that may correspond to electrographic seizures for the purpose of reviewing prolonged EEG traces. The marked events are reviewed, possibly deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information. IdentEvent also includes the display of the quantitative EEG parameters Amplitude Variation and Maximum Frequency, which are intended to help the user analyze the EEG waveform after it has been collected. IdentEvent requires the use of EEGs recorded with at least a 16-channel scalp montage following the standard 10/20 electrode placement system. IdentEvent does not provide any diagnostic conclusion about the patient's condition to the user.
    Device Description
    IdentEvent® is a software-only product with an algorithm intended to analyze previously acquired, adult (≥18 years) scalp EEG signals and mark events that may correspond to electrographic seizures for the purpose of reviewing prolonged EEG traces. The marked events are reviewed, possibly deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information. IdentEvent also includes the display of the quantitative EEG parameters Amplitude Variation and Maximum Frequency, which are intended to help the user analyze the EEG waveform after it has been collected. IdentEvent requires the use of EEGs recorded with at least a 16-channel scalp montage following the standard 10/20 electrode placement system. IdentEvent does not provide any diagnostic conclusion about the patient's condition to the user.
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    K Number
    K092039
    Device Name
    IDENTEVENT, VERSION 1.0G
    Manufacturer
    OPTIMA NEUROSCIENCE, INC.
    Date Cleared
    2009-10-16

    (102 days)

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

    OPTIMA NEUROSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IdentEvent ™ is a software-only product with an algorithm intended to analyze previously acquired, adult (≥18 years) scalp EEG signals and mark events that may correspond to electrographic seizures for the purpose of reviewing prolonged EEG traces. The marked events are reviewed, possibly deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information. IdentEvent also includes the display of the quantitative EEG parameters Amplitude Variation and Maximum Frequency, which are intended to help the user analyze the EEG waveform after it has been collected. IdentEvent requires the use of EEGs recorded with at least a 16-channel scalp montage following the standard 10/20 electrode placement system. IdentEvent does not provide any diagnostic conclusion about the patient's condition to the user.
    Device Description
    Optima's IdentEvent™ analyzes digital scalp electroencephalograph (EEG) signals recorded from standard recording systems and displays information about brain electrical activity to the user. The application only analyzes and displays information from previously recorded digital EEG files. IdentEvent is designed for post-hoc EEG review of long-term EEG recordings, including the detection of seizure events. IdentEvent requires previously recorded, digitized scalp EEG recordings with electrodes placed according to the standard 10/20 system. The recording can then be automatically analyzed to detect seizures which are then marked for review by the user. IdentEvent includes the following features (outputs): * Display of raw & filtered EEG signals for review * Display of the following quantitative EEG (qEEG) measures: * Amplitude Variation * Maximum Frequency * Review (and possible deletion) of detected seizures * Entry, editing and display of user-entered comments * Graphical and text reports of detected seizures and comments.
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