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U.S. Department of Health and Human Services

Product Classification

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Device source localization software for electroencephalograph or magnetoencephalograph
Regulation Description Electroencephalograph.
Definition Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
Physical State Software algorithm. Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software used as the only or final electroencephalograph analysis step, electroencephalograph software with comparative databases (normal or otherwise) or electroencephalograph software that outputs an index, diagnosis, or classification.
Technical Method Uses software algorithms that correlate the electroencephalograph to one or several types of neuroimaging data. May include use of event-detection algorithms (that require user confirmation) as an intermediary, but not final, step.
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeOLX
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons