# Viasonix, Ltd.

- Location (FDA's records): Ra'Anana, IL
- FDA decisions: 6 (2011–2024): 6 510(k) clearances
- Product codes: IYN (3), JOP (2), IRP (1)
- 510(k) review time since 2016: median 110 days, against 83 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 6 (3 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
- Nicolet Biomedical, Inc.: 1 (https://510kreport.com/company/nicolet-biomedical)
- Unetixs, Inc.: 1 (https://510kreport.com/company/unetixs)
- Viasys Healthcare GmbH: 1 (https://510kreport.com/company/viasys-healthcare)
- Compumedics Germany Gmgh: 1 (https://510kreport.com/company/compumedics-germany-gmgh)
- Ahava Stein: 1 (https://510kreport.com/company/ahava-stein)

## Firms that cite its devices most
- Corvascular Diagnostics, LLC: 1 (https://510kreport.com/company/corvascular-diagnostics)
- Us Vascular, LLC: 1 (https://510kreport.com/company/us-vascular)
- Koven Technology, Inc.: 1 (https://510kreport.com/company/koven-technology)

## Its most-cited devices
- K111416: Falcon (2011), cited by 4
- K170859: Dolphin/IQ and Dolphin/4D (2017), cited by 1
- K191023: Dolphin/IQ, Dolphin/4D and Dolphin/MAX (2019), cited by 1

## Recent decisions
- K242662: Falcon/Xpress (Falcon/Xpress) (Dec 18, 2024)
- K202742: Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory (Jan 25, 2021)
- K192607: LiteWalk (Dec 19, 2019)
- K191023: Dolphin/IQ, Dolphin/4D and Dolphin/MAX (May 16, 2019)
- K170859: Dolphin/IQ and Dolphin/4D (Nov 14, 2017)
- K111416: Falcon (Jul 15, 2011)

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