510(k) K111674 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON
| Applicant | Siemens Medical Solutions USA, Inc., Mountainview CA, US |
| Decision | Substantially Equivalent, Jun 30, 2011 |
| Received | Jun 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111674
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2012 | Siemens Medical Solutions USA, Inc. Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial
compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10041461 - ACUSON S2000 M Terminated |
IYO | None listed |
| May 30, 2012 | Siemens Medical Solutions USA, Inc. Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial
compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A);
Model #: 10440017 - ACUSON S2000 Terminated |
IYO | None listed |
| May 16, 2012 | Siemens Medical Solutions USA, Inc. ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an ultrasound imaging system. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.