The Cognitive Function Neuroimaging (cfNI) software is to be used by qualified healthcare professionals for the digital post-hoc statistical analysis of the human electroencephalogram (“EEG”), including event-related potentials (“ERPs”). This device is indicated for use in individuals 18 to 70 years of age, and in conjunction with Resting State, Auditory Oddball, Go No-Go, Continuous Visual Memory Test, and Eriksen Flanker tasks. The cfNI software compares EEG measures to a reference database and produces an outcome report to support interpretation by a qualified user. This includes measures that are typical for technologies regulated under product code OLU (e.g., event-related potentials (ERPs), power, frequency ratios, etc.). The cfNI software system also includes functionality for EEG data acquisition and synchronized auditory/visual stimulus presentation, enabling the user to acquire and record the synchronized EEG and stimulus-response input data necessary for downstream processing and analysis. The device does not provide a diagnosis or clinical interpretation. It is for prescription-use only.
A software program intended to acquire and process neurological physiological parameter data [primarily electroencephalographic (EEG)] to assist a healthcare professional in the diagnosis of neurological conditions. It has a general-purpose neurological use and is not dedicated to, e.g., sleep monitoring, psychiatric analysis, or seizure-detection.