510(k) K201462 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON Sequoia Diagnostic Ultrasound System
| Applicant | Siemens Medical Solutions USA, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Jun 24, 2020 |
| Received | Jun 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201462
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2021 | Siemens Medical Solutions USA, Inc. ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.