FDA Product Code NCG: Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Uses A Patient's Electroencephalograph (eeg) To Provide An Interpretation Of The Patient's Neuropsychiatric Condition. It Is Also Used Only As An Assessment Aid For A Medical Condition For Which There Exists Other Valid Methods Of Diagnosis."
Leading manufacturers include Ceribell, Inc. and Prolira B.V..
FDA 510(k) Cleared Neuropsychiatric Interpretative Electroencephalograph Assessment Aid Devices (Product Code NCG)
About Product Code NCG - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code NCG since 2013, with 2 receiving FDA clearance (average review time: 300 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under NCG have taken an average of 167 days to reach a decision - down from 367 days historically, suggesting improved FDA processing for this classification.
NCG devices are reviewed by the Neurology panel. Browse all Neurology devices →