510(k) K222191 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
| Applicant | Supersonic Imagine, Aix En Provence, FR |
| Decision | Substantially Equivalent, Oct 28, 2022 |
| Received | Jul 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222191
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.