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510(k) Data Aggregation

    K Number
    K250058
    Device Name
    NEAT 001
    Manufacturer
    Brain Electrophysiology Laboratory Company, LLC
    Date Cleared
    2025-04-10

    (90 days)

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

    Brain Electrophysiology Laboratory Company, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Automatic scoring of sleep EEG data to identify stages of sleep according the American Academy of Sleep Medicine definitions, rules and guidelines. It is to be used with adult populations.
    Device Description
    The Neurosom EEG Assessment Technology (NEAT) is a medical device software application that allows users to perform sleep staging post-EEG acquisition. NEAT allows users to review sleep stages on scored MFF files and perform sleep scoring on unscored MFF files. NEAT software is designed in a client-server model and comprises a User Interface (UI) that runs on a Chrome web browser in the client computer and a Command Line Interface (CLI) software that runs on a Forward-Looking Operations Workflow (FLOW) server. The user interacts with the NEAT UI through the FLOW front-end application to initiate the NEAT workflow on unscored MFF files and visualize sleep-scoring results. Sleep stages are scored by the containerized neat-cli software on the FLOW server using the EEG data. The sleep stages are then added to the input MFF file as an event track file in XML format. Once the new event track file is created, the NEAT UI component retrieves the sleep events from the FLOW server and displays a hypnogram (visual representation of sleep stages over time) on the screen, along with sleep statistics and other subject details. Additionally, a summary of the sleep scoring is automatically generated and added to the same participant in the FLOW server in PDF format.
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    K Number
    K241513
    Device Name
    Sourcerer
    Manufacturer
    Brain Electrophysiology Laboratory Company, LLC
    Date Cleared
    2024-09-27

    (121 days)

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

    Brain Electrophysiology Laboratory Company, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The software is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 16 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an idealized head model and an idealized MRI image.
    Device Description
    Sourcerer is an EEG source localization software that uses EEG and MRI-derived information to estimate and visualize cortex projections of human brain activity. Sourcerer is designed in a client-server model wherein the server components integrate directly with FLOW - BEL's software. Inverse source projections are computed on the server using EEG and MRI data from FLOW using the Electro-magnetic Inverse Module (EMIM API). The inverse results are interactively visualized in the Chrome browser running on the client computer using the Electro-magnetic Functional Anatomy Viewer (EMFAV).
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