510(k) K050034 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Jan 13, 2005 |
| Received | Jan 7, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2011 | Siemens Medical Solutions USA, Inc. Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.