510(k) K010721 ยท IZI System, X-Ray, Angiographic
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
| Applicant | Siemens Medical Corp., Iselin NJ, US |
| Decision | Substantially Equivalent, Mar 30, 2001 |
| Received | Mar 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010721
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2017 | Siemens Medical Solutions USA, Inc Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813. Terminated |
OWB | None listed |
| Jul 13, 2016 | Siemens Medical Solutions USA, Inc AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic
AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane dia Terminated |
IZI | None listed |
| Aug 5, 2015 | Siemens Medical Solutions USA, Inc Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Proce Terminated |
IZI | None listed |
| Sep 24, 2014 | Siemens Medical Solutions USA, Inc AXIOM Artis or Artis zee system
Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures in Terminated |
IZI | None listed |
| Aug 16, 2010 | Siemens Medical Solutions USA, Inc AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system. Terminated |
IZI | None listed |
| Dec 3, 2009 | Siemens Medical Solutions USA, Inc Axiom Artis MP, Model number 5904466
angiographic x-ray systems Terminated |
IZI | None listed |
| Jun 16, 2009 | Siemens Medical Solutions USA, Inc Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 7559375 Upper Body radiation shield, Artis T. Terminated |
IZI | None listed |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807. Terminated |
IZI | None listed |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dBC-M, Axiom Artis Modular Angiography X-Ray System, Model number 5917054. Terminated |
IZI | None listed |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model number 7008605. Terminated |
IZI | None listed |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model number 7413078. Terminated |
IZI | None listed |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357. Terminated |
IZI | None listed |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray System, Model number 7727717. Terminated |
IZI | None listed |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dFA, Axiom Artis Modular Angiography X-Ray System, Model number 7555373. Terminated |
IZI | None listed |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray System, Model number 7555365. Terminated |
IZI | None listed |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392. Terminated |
IZI | None listed |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis. Angiographic X-ray System. Terminated |
IZI | None listed |
| Mar 8, 2007 | Siemens Medical Solutions USA, Inc AXIOM Artis MP, Angiographic x-ray system, model number 5904466 Terminated |
IZI | None listed |
| Mar 8, 2007 | Siemens Medical Solutions USA, Inc AXIOM Artis MP, Angiographic x-ray system, model number 7555365 Terminated |
IZI | None listed |
| May 11, 2005 | Siemens Medical Solutions USA, Inc Axiom Artis MP X-Ray System Terminated |
IZI | None listed |
| May 3, 2005 | Siemens Medical Solutions USA, Inc Axiom Artis X-Ray System using software version VB11D or VB20B Terminated |
IZI | None listed |
| Sep 14, 2004 | Siemens Medical Solutions USA, Inc Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649 Terminated |
IZI | None listed |
| Sep 14, 2004 | Siemens Medical Solutions USA, Inc Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 656 Terminated |
IZI | None listed |
| Jul 20, 2004 | Siemens Medical Solutions USA, Inc Axiom Artis System Terminated |
IZI | None listed |
| Jul 20, 2004 | Siemens Medical Solutions USA, Inc SIEMENS AXIOM Artis - AUTOMAP FUNCTION Terminated |
IZI | None listed |
| Dec 18, 2002 | Siemens Medical Systems Inc Axiom Artis System, X-ray, Angiographic Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.