NCG — Neuropsychiatric Interpretative Electroencephalograph Assessment Aid Class II

FDA Device Classification

Classification Details

Product Code
NCG
Device Class
Class II
Regulation Number
882.1440
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

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."

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251936ceribellCeribell Delirium Monitor SystemDecember 8, 2025
K222680proliraDeltaScan MonitorFebruary 2, 2023
DEN110019lexicor medical technologyNEBA SYSTEMJuly 15, 2013