# OEO: Automated Digital Image Manual Interpretation Microscope

- Device class: 2; regulation: 21 CFR 864.1860; 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)
- 2007: 1
- 2008: 1
- 2012: 1
- 2013: 1
- 2014: 1
- 2015: 1

## Most-cited predicates
- K071671: Scanscope XT System (2007), cited by 4
- K111914: Virtual Slide System, Olympus VS800 System (2012), cited by 1

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