510(k) K090745 ยท IZI System, X-Ray, Angiographic
ARTIS ZEE / ZEEGOS WITH SW VC14
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jun 18, 2009 |
| Received | Mar 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090745
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2017 | Siemens Medical Solutions USA, Inc Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813. Terminated |
OWB | None listed |
| Nov 14, 2013 | Siemens Medical Solutions USA, Inc Artis zee systems
x-ray, angiographic system Terminated |
IZI | None listed |
| Aug 9, 2013 | Siemens Medical Solutions USA, Inc Siemens AXIOM Artis zeego
x-ray, angiographic system Terminated |
IZI | None listed |
| Jul 22, 2013 | Siemens Medical Solutions USA, Inc ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed.
Angiographic x-ray system Terminated |
IZI | None listed |
| Jul 17, 2013 | Siemens Medical Solutions USA, Inc Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus
Product Usage:
Angiographic x-ray system Terminated |
IZI | None listed |
| Mar 26, 2013 | Siemens Medical Solutions USA, Inc Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed.
Angiographic x-ray system Terminated |
IZI | None listed |
| Mar 25, 2013 | Siemens Medical Solutions USA, Inc Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration
Angiographic x-ray system Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.