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Persyst 14 Review and Analysis Software
Persyst 14 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Details
Device typeBioelectrical signal analysis software: A software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.
FDA categoryAmplitude-Integrated Electroencephalograph, Automatic Event Detection Software For Full-Montage Electroencephalograph, Non-Normalizing Quantitative Electroencephalograph Software
Device ID00869732000128
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information