# Viseon, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 2 (2018–2019): 2 510(k) clearances
- Product codes: HRX (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (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
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)

## Firms that cite its devices most
- Medos International SARL: 1 (https://510kreport.com/company/medos-international)

## Its most-cited devices
- K181885: Voyant System (2018), cited by 1
- K191579: Voyant System (2019), cited by 1

## Recent decisions
- K191579: Voyant System (Jul 11, 2019)
- K181885: Voyant System (Oct 2, 2018)

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