510(k) K182628 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Imagio Ultrasound Imaging System
| Applicant | Seno Medical Instruments, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Mar 5, 2019 |
| Received | Sep 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182628
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.