# O.N. Diagnostics

- Location (FDA's records): Berkeley, CA
- FDA decisions: 3 (2012–2023): 3 510(k) clearances
- Names in FDA's records: O.N. Diagnostics (2); O.N. Diagnostics, LLC (1)
- Product codes: KGI (2), LLZ (1)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Optasia Medical: 1 (https://510kreport.com/company/optasia-medical)
- Ge Lunar Corp.: 1 (https://510kreport.com/company/ge-lunar)
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)
- Image Enhancements: 1 (https://510kreport.com/company/image-enhancements)
- Ge Medical Systems Ultrasound and Primary Care Dia: 1 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-dia)
- Image Analysis, Inc.: 1 (https://510kreport.com/company/image-analysis)

## Its most-cited devices
- K113725: Virtuost (2012), cited by 1

## Recent decisions
- K220402: VirtuOst (May 19, 2023)
- K171435: VirtuOst Vertebral Fracture Assessment (Aug 3, 2018)
- K113725: Virtuost (Sep 13, 2012)

Source page: https://510kreport.com/company/on-diagnostics