510(k) K123001 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Moutain View CA, US |
| Decision | Substantially Equivalent, Oct 26, 2012 |
| Received | Sep 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123001
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2015 | Siemens Medical Solutions USA, Inc. ACUSON X700 Ultrasound System with software version 1.0.04.
Model numbers:
10658844 ACUSON X700 Ultrasound System
10658846 - ACUSON X700 Ultrasound System (Russia)
10658845 - ACUSON X700 Ultrasound S Terminated |
IYN | None listed |
| Apr 24, 2014 | Siemens Medical Solutions USA, Inc. Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. 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.