# OEW: Tracking, Soft Tissue, Intraoperative

- Device class: 2; regulation: 21 CFR 882.4560; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 2007: 1
- 2010: 1
- 2011: 1
- 2015: 1

## Most-cited predicates
- K071063: Linasys (2007), cited by 3
- K101979: Explorer Liver (Passive Tracking) (2011), cited by 1
- K093494: Linasys Image-Guided Liver Surgery System (2010), cited by 1

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