# Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)

- Location (FDA's records): Tucson
- FDA decisions: 3 (2021–2026): 3 original PMA approvals
- Product codes: QNH (1), SER (1), SHF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- P250031: VENTANA PTEN (SP218) RxDx Assay (Jun 12, 2026)
- P240037: VENTANA MET (SP44) RxDx Assay (May 14, 2025)
- P210001: VENTANA MMR RxDx Panel (Aug 17, 2021)

Source page: https://510kreport.com/company/ventana-medical-systems-roche-tissue-diagnostics