# SAO: Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

- Device class: 2; regulation: 21 CFR 892.1171; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 119 days (middle half 119–119)
- 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)
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- DEN230023: Rho (2024), cited by 2

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