# Vysis

- Location (FDA's records): Downers Grove, IL
- FDA decisions: 9 (1996–2004): 8 510(k) clearances and 1 De Novo grant
- Product codes: OYU (3), MMW (3), NTH (1), OXP (1), OVQ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Bioview, Ltd.: 4 (https://510kreport.com/company/bioview)
- Ikonisys, Inc.: 1 (https://510kreport.com/company/ikonisys)
- Nucleix, Ltd.: 1 (https://510kreport.com/company/nucleix)

## Its most-cited devices
- DEN040010: Vysis Autovysion System (2004), cited by 3
- K013785: Urovysion Bladder Cancer Recurrence Kit (2002), cited by 1
- K011031: Vysis Urovysion Bladder Cancer Recurrence Kit (2001), cited by 1
- K033982: Modification to Vysis Urovysion Bladder Cancer Recurrence Test (2004), cited by 1

## Recent decisions
- DEN040010: Vysis Autovysion System (Dec 13, 2004)
- K033982: Modification to Vysis Urovysion Bladder Cancer Recurrence Test (Jan 22, 2004)
- K013785: Urovysion Bladder Cancer Recurrence Kit (Feb 8, 2002)
- K011031: Vysis Urovysion Bladder Cancer Recurrence Kit (Aug 3, 2001)
- K010288: Aneuvysion Muliticolor Dna Probe Kit (Apr 13, 2001)
- K972200: Aneuvysion (Oct 20, 1997)
- K954214: Cep X Spectrumorange\Y Spectrumgreen Dna Probe Kit (Jan 21, 1997)
- K962873: Cep 12 Spectrumorange Direct Labeled Chromosome Enumeration Dna Probe (Jan 13, 1997)

Source page: https://510kreport.com/company/vysis