# OEB: Lung Computed Tomography System, Computer-Aided Detection

- Device class: 2; regulation: 21 CFR 892.2050; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 207 days (middle half 175–264)
- 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)
- 2006: 1
- 2007: 1
- 2015: 1
- 2016: 1
- 2020: 2
- 2021: 2
- 2022: 1
- 2023: 2
- 2025: 3
- 2026: 1

## Most-cited predicates
- K033374: Lungcare CT Software Package with Extended Functionality (2003), cited by 5
- K161201: ClearRead CT (2016), cited by 4
- K042694: Advanced Lung Analysis II (2004), cited by 3
- K143196: syngo.CT Lung CAD (2015), cited by 3
- K221592: AVIEW Lung Nodule CAD (2023), cited by 2
- K041380: Imagechecker-CT Software Package with Filling Defect Indicator (2004), cited by 2
- K203258: syngo.CT Lung CAD (2021), cited by 2
- K192880: InferRead Lung CT.AI (2020), cited by 1
- K063877: Syngo Lung Cad (2006), cited by 1
- K043617: Imagechecker CT Cad Software System (2007), cited by 1

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