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510(k) Data Aggregation

    K Number
    K222838
    Device Name
    iSyncBrain©-C
    Manufacturer
    iMediSync Inc.
    Date Cleared
    2023-03-16

    (177 days)

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

    iMediSync Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iSyncBrain-C is to be used by qualified medical or qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG) in patients aged 4.5 to 81 years.
    Device Description
    iSyncBrain-C is a software program for the post-hoc statistical analysis of the human electroencephalogram (EEG). EEG signals can be measured by various EEG equipment, and the measured EEG data is saved in EDF files. iSyncBrain-C can upload, and analyze these EDF files, and personal information or results are automatically stored in AWS (Amazon Web Serve). The analysis consists of the Fast-Fourier Transformation (FFT) of the data to extract the spectral power for each of the designated frequency bands (e.g., Delta, Theta, Alpha, Alpha2, Beta2, Beta3, Gamma) and frequency information from the EEG. These analysis results are displayed in statistical tables and topographical brain maps of absolute and relative power, power ratio, ICA components, power spectrum, occipital alpha peak, source ROI power(sLORETA) & connectivity(iCoh). All EEG devices has its own frequency characteristics which should be included for any data comparisons coming from different devices. iSyncBrain-C has an EEG amplifier matching module where frequency spectra are adjusted with calibration table between database amplifier and recording amplifier. In all over 33,000 measures are derived for comparison against carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution. Each variable extracted by the analysis is compared to the database using parametric statistical procedures that express the differences between the subject and an appropriate sex/aqematched reference group in the form of z-scores.
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    K Number
    K220056
    Device Name
    iSyncWave
    Manufacturer
    iMediSync Inc.
    Date Cleared
    2022-08-10

    (216 days)

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

    iMediSync Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iSyncWave is intended for prescription use in a health care facility to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.
    Device Description
    iSyncWave™ is a wireless EEG measurement device that applies dry EEG measurement technology to an international 10-20 system compliant size-adjustable headset. iSyncWave™ measures 19 channel EEG in real time and transfers the data through BLE wireless connection to the iSyncWave™ App. The data is displayed and recorded via the iSyncWave™ App. iSyncWave™ uses dry electrode technology, which doesn't require a preparation process(e.g., applyinq conductive gel), to obtain high quality EEG signals. Before measuring the EEG, you can check the impedance of each electrode under the impedance check screen in the iSyncWave™ app. An EEG amplifier, analog-to-digital converter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz and then converted to digital data at 24-bit resolution. This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and 1 ground electrode. The measured data can be digitally converted to common average, longitudinal and transverse montage. The measured data is automatically uploaded to a secure cloud server via Wi-Fi connection and saved securely. The data saved in the cloud server can be seen on the iSyncWave™ app.
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