510(k) K211859 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON Sequoia Diagnostic Ultrasound System
| Applicant | Siemens Medical Solutions USA, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Jul 20, 2021 |
| Received | Jun 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211859
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2022 | Siemens Medical Solutions USA, Inc. Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.