# NCG: Neuropsychiatric Interpretative Electroencephalograph Assessment Aid

- Device class: 2; regulation: 21 CFR 882.1440; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 158 days (middle half 154–163)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K222680: DeltaScan Monitor (2023), cited by 1
- DEN110019: Neba System (2013), cited by 1

Source page: https://510kreport.com/product-code/NCG
Data by year (CSV): https://510kreport.com/product-code/NCG.csv