510(k) K191007 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
| Applicant | Supersonic Imagine, Aix-En-Provence Cedex, FR |
| Decision | Substantially Equivalent, Oct 25, 2019 |
| Received | Apr 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191007
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.