510(k) K220983 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
| Applicant | Imsonic Medical China, Inc., Kunshan, CN |
| Decision | Substantially Equivalent, Nov 11, 2022 |
| Received | Apr 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220983
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.