510(k) K142876 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
| Applicant | Siemens Medical Solutions USA, Inc., Moutain View CA, US |
| Decision | Substantially Equivalent, Oct 23, 2014 |
| Received | Oct 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142876
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2015 | Siemens Medical Solutions USA, Inc. ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines
6C1HD - model numbers:
10442008 6C1HD Needle Guide, S3000;
10440586 6C1 HD Biopsy Guide, S2000
18L6 - model nu Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.