Product Classification

• Device: magnetoencephalograph
• Regulation Description: Electroencephalograph.
• Definition: Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.
• Physical State: Magnetoencephalograph recording device (hardware, basic software)
• Technical Method: Uses a helmet with sensors to record the magnetic activity of the brain
• Target Area: Brain
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: OLY
• Premarket Review: Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A); 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