# OLY: Magnetoencephalograph

- Device class: 2; regulation: 21 CFR 882.1400; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 1986: 1
- 1996: 1
- 1997: 1
- 2014: 1
- 2016: 1
- 2020: 1

## Most-cited predicates
- K962764: Neuromag-122 (1996), cited by 4
- K962317: Magnes 2500 WH Biomagnetometer (1997), cited by 2

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