510(k) K163635 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
| Applicant | Siemens Medical Solutions USA, Inc. Ultrasound Group, Moutain View CA, US |
| Decision | Substantially Equivalent, Jan 12, 2017 |
| Received | Dec 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163635
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2017 | Siemens Medical Solutions USA, Inc. 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C;
Model numbers:
18L6 HD transducer 10041227 & 10789400
S1000 10441701
S2000 10041461
S2000 (Refur Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.