# OLX: Source Localization Software For Electroencephalograph Or Magnetoencephalograph

- Device class: 2; regulation: 21 CFR 882.1400; FDA's rule: 510(k) required
- FDA decisions: 25
- 510(k) review time 2021–2025: median 135 days (middle half 120–151)
- 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)
- 2005: 1
- 2007: 1
- 2008: 1
- 2010: 3
- 2018: 1
- 2020: 1
- 2021: 1
- 2024: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K041264: Elekta OY (2004), cited by 6
- K001781: Curry Multimodal Neuroimaging Software (2001), cited by 3
- K901215: 700 Series Biomagnetometer (1990), cited by 3
- K172858: PreOp (2018), cited by 2
- K030737: Omega Whole-Cortex MFG System, Models Omega 151, Omega 275 (2003), cited by 2
- K050035: Elekta Neuromag with Maxwell Filter (2005), cited by 2
- K092844: Geosource (2010), cited by 2
- K201910: EZTrack (2020), cited by 1
- K002631: Electroencephalograph Software Eemagine Eeg (2000), cited by 1
- K233985: TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) (2024), cited by 1

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