NCGClass II
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
21 CFR 882.1440 / Neurology
NCG is the FDA product code for Neuropsychiatric Interpretative Electroencephalograph Assessment Aid, a class II device type, regulated under 21 CFR 882.1440. FDA's definition for this code reads: "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."". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NCG
- Device name
- Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
- FDA 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."
- Regulation
- 21 CFR 882.1440
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code NCG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2023 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code NCG| Applicant | Clearances |
|---|---|
| Ceribell, Inc. | 1 |
| Lexicor Medical Technology, Inc. | 1 |
| Prolira B.V. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.