# Ventana Medical Systems, Inc.

- Location (FDA's records): Tucson, AZ
- FDA decisions: 62 (1992–2024): 46 510(k) clearances, 3 De Novo grants and 13 original PMA approvals
- Names in FDA's records: Ventana Medical Systems, Inc. (60); Ventana Medical Systems (2)
- Product codes: DEH (17), NQN (6), DEM (5), NOT (4), PLS (3), DEY (3), DFD (3), NYQ (2), PSY (2), PRB (2), OWF (1), QNH (1)
- Predicates its devices cite: 19 (9 its own); citations of its devices by later devices: 18 (9 its own)
- Recalls linked to its devices: 7 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bioimagene, Inc.: 3 (https://510kreport.com/company/bioimagene)
- Aperio Technologies: 2 (https://510kreport.com/company/aperio-technologies)
- Arj Medical, Inc.: 1 (https://510kreport.com/company/arj-medical)
- Leica Biosystems Imaging, Inc.: 1 (https://510kreport.com/company/leica-biosystems-imaging)
- Dako Corp.: 1 (https://510kreport.com/company/dako)
- Dako North America, Inc.: 1 (https://510kreport.com/company/dako-north-america)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)

## Firms that cite its devices most
- Applied Spectral Imaging, Ltd.: 4 (https://510kreport.com/company/applied-spectral-imaging)
- Lab Vision Corp.: 1 (https://510kreport.com/company/lab-vision)
- Leica Biosystems Newcastle, Ltd.: 1 (https://510kreport.com/company/leica-biosystems-newcastle)
- Omnyx, LLC: 1 (https://510kreport.com/company/omnyx)
- Promega Corporation: 1 (https://510kreport.com/company/promega)
- Biogenex Laboratories: 1 (https://510kreport.com/company/biogenex-laboratories)

## Its most-cited devices
- K111869: Virtuoso System for Ihc PR (IE2) (2012), cited by 4
- K111543: Virtuoso (TM) System for Ihc HER2 (4B5) (2011), cited by 2
- K990618: Ventana PGR Primary Antibody (Clone 1A6) (1999), cited by 2
- DEN170030: VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129)  Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody (2017), cited by 2
- K130515: Virtuoso System for Ihc ER (Spi) (2013), cited by 2
- K111755: Virtuoso System for Ihc KI-67 (30-9) (2012), cited by 2

## Recent decisions
- K242783: Roche Digital Pathology Dx (Dec 17, 2024)
- DEN240025: VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (Dec 5, 2024)
- P230018: VENTANA CLDN18 (43-14A) RxDx Assay (Oct 18, 2024)
- K232879: Roche Digital Pathology Dx (VENTANA DP 200) (Jun 14, 2024)
- P220006: VENTANA FOLR1 (FOLR-2.1) RxDx Assay (Nov 14, 2022)
- K212176: CINtec Histology (Dec 10, 2021)
- P200019: VENTANA MMR RxDx Panel (Apr 22, 2021)
- P190031: HER2 Dual ISH DNA Probe Cocktail (Jul 28, 2020)

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