510(k) K061946 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Jul 21, 2006 |
| Received | Jul 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061946
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 8, 2008 | Siemens Medical Solutions USA, Inc. Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software revision 1.0.06 and 1.0.07, Acuson X300 sofware revision 1.0.08 ultrasound system with onscreen Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.