# ONX: Ovarian Adnexal Mass Assessment Score Test System

- Device class: 2; regulation: 21 CFR 866.6050; 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)
- 2009: 1
- 2011: 1
- 2016: 4

## Most-cited predicates
- K103358: Roma (HE4 Eia + Architect CA 125 II) (2011), cited by 3
- DEN090004: OVA1 Test (2009), cited by 2

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