Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
The Neuropsychiatric Interpretative Electroencephalograph (EEG) Assessment Aid is a software-based device that analyzes a patient's electroencephalogram (EEG) recording and provides an interpretation or assessment of the patient's neuropsychiatric condition to assist clinicians in diagnosis. It is intended to be used only as an assessment aid alongside other valid diagnostic methods. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 882.1440 (Neurology specialty).
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Basic Information
- Product Code
- NCG
- Device Class
- FDA class 2
- Regulation Number
- 882.1440
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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."
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.