Viasonix , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Viasonix , Ltd.” (first 2011, latest 2024), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 98 days. Since 2017 the median was 105 days, against 103 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 237 |
| 2018 | 0 | — |
| 2019 | 2 | 60 |
| 2020 | 0 | — |
| 2021 | 1 | 129 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 105 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Viasonix , Ltd. took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 | 3 |
| JOP | Transducer, Ultrasonic | 2 | 2 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
Review panels
- Radiology (3)
- Cardiovascular (2)
- Physical Medicine (1)
Most recent Viasonix , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242662 | Falcon/Xpress (Falcon/Xpress) | JOP | 2024-12-18 | 105 |
| K202742 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory | IYN | 2021-01-25 | 129 |
| K192607 | LiteWalk | IRP | 2019-12-19 | 90 |
| K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | IYN | 2019-05-16 | 29 |
| K170859 | Dolphin/IQ and Dolphin/4D | IYN | 2017-11-14 | 237 |
| K111416 | FALCON | JOP | 2011-07-15 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Viasonix , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Viasonix , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Viasonix , Ltd.” (first 2011, latest 2024), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Viasonix , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Viasonix , Ltd. is 98 days. Since 2017: 105 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Viasonix , Ltd.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 3); JOP (Transducer, Ultrasonic, 2); IRP (Massager, Powered Inflatable Tube, 1).
Next steps
- See all 6 Viasonix , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Viasonix , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.