510(k) K193257 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON Sequoia Diagnostic Ultrasound System
| Applicant | Siemens Medical Solutions USA, Inc., Moutain View CA, US |
| Decision | Substantially Equivalent, Jan 31, 2020 |
| Received | Nov 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193257
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2021 | Siemens Medical Solutions USA, Inc. Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model
User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.