510(k) K210743 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON Redwood Diagnostic Ultrasound System
| Applicant | Siemens Medical Solutions USA, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Apr 1, 2021 |
| Received | Mar 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2024 | Siemens Medical Solutions USA, Inc. ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software Open, Classified |
IYN | None listed |
| Apr 19, 2024 | Siemens Medical Solutions USA, Inc. ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G Open, Classified |
IYN | None listed |
| Sep 13, 2023 | Siemens Medical Solutions USA, Inc. ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.