510(k) K191023 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Dolphin/IQ, Dolphin/4D and Dolphin/MAX
| Applicant | Viasonix , Ltd., Ra'Anana, IL |
| Decision | Substantially Equivalent, May 16, 2019 |
| Received | Apr 17, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191023
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.