Product Classification

• 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 Code: OLX
• 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc