510(k) K180572 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
| Applicant | Supersonic Imagine, Aix-En-Provence Cedex, FR |
| Decision | Substantially Equivalent, May 29, 2018 |
| Received | Mar 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180572
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.