510(k) K073290 ยท IZI System, X-Ray, Angiographic
ARTIS ZEE AND ZEEGO
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Feb 11, 2008 |
| Received | Nov 21, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073290
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2019 | Siemens Medical Solutions USA, Inc Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and i Terminated |
IZI | None listed |
| Apr 9, 2019 | Siemens Medical Solutions USA, Inc Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional proced Terminated |
IZI | None listed |
| Oct 26, 2018 | Siemens Medical Solutions USA, Inc Artis Zee and Zeego, model no. 10272462
AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, Terminated |
IZI | None listed |
| Oct 19, 2018 | Siemens Medical Solutions USA, Inc ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system
Product Usage:
Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interv Terminated |
IZI | None listed |
| 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 |
| Aug 24, 2017 | Siemens Medical Solutions USA, Inc AArtis Q/ Q.Zen biplane
Artis zee biplane
Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, Terminated |
OWB | None listed |
| Jun 6, 2017 | Siemens Medical Solutions USA, Inc Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354 Terminated |
IZI | None listed |
| Mar 30, 2017 | Siemens Medical Solutions USA, Inc Artis zee, Angiographic x-ray system Terminated |
IZI | None listed |
| Feb 27, 2017 | Siemens Medical Solutions USA, Inc Artis Zee and Zeego fluoroscopic x-ray system Terminated |
IZI | None listed |
| Feb 3, 2017 | Siemens Medical Solutions USA, Inc Artis zee,x-ray system, angiographic
Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limite Terminated |
IZI | None listed |
| Jul 13, 2016 | Siemens Medical Solutions USA, Inc ARTIS ZEE AND ZEEGO, 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 diagnostic imaging and Terminated |
IZI | None listed |
| Jul 7, 2016 | Siemens Medical Solutions USA, Inc Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled
Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255
Artis zee / Terminated |
IZI | None listed |
| Mar 31, 2016 | Siemens Medical Solutions USA, Inc system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959
Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging Terminated |
IZI | None listed |
| Mar 31, 2016 | Siemens Medical Solutions USA, Inc AXIOM Artis zee/zeego, system, x-ray, angiographic
Product Usage:
AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and inte Terminated |
IZI | None listed |
| Feb 19, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operati Terminated |
IZI | None listed |
| Feb 18, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic
AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve Terminated |
IZI | None listed |
| Feb 18, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic
AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve Terminated |
IZI | None listed |
| Feb 18, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic
AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve Terminated |
IZI | None listed |
| Feb 18, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic
AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve Terminated |
IZI | None listed |
| Feb 18, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic
AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve Terminated |
IZI | None listed |
| Feb 18, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic
AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve Terminated |
IZI | None listed |
| Feb 18, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic
AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve Terminated |
IZI | None listed |
| Feb 18, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic
AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve Terminated |
IZI | None listed |
| Dec 24, 2015 | Siemens Medical Solutions USA, Inc Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures. Terminated |
OWB | None listed |
| Aug 5, 2015 | Siemens Medical Solutions USA, Inc Siemens Artis zee systems;
dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Terminated |
IZI | None listed |
| Jan 14, 2015 | Siemens Medical Solutions USA, Inc Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedu Terminated |
IZI | None listed |
| Dec 1, 2014 | Siemens Medical Solutions USA, Inc The Artis zee / zeego Angiography System is designed as a set of components that
may be combined into different configurations to provide specialized angiography systems. Terminated |
IZI | None listed |
| Nov 7, 2014 | Siemens Medical Solutions USA, Inc Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedu 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 |
| Sep 22, 2014 | Siemens Medical Solutions USA, Inc Artis zee and Artis zeego systems.
x-ray, angiographic system Terminated |
IZI | None listed |
| Mar 31, 2014 | Siemens Medical Solutions USA, Inc Artis Zee Angiographic x-ray systems. Terminated |
IZI | None listed |
| Mar 22, 2014 | Siemens Medical Solutions USA, Inc AXIOM Artis Systems
Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited Terminated |
IZI | None listed |
| Feb 24, 2014 | Siemens Medical Solutions USA, Inc Siemens Artis zee Ceiling Systems.
Angiographic x-ray 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 |
| 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 |
| 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 Zee Multi-purpose, Model number 10094139
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 10281153 3-bulb surgery lamp, 115V. Terminated |
JAK | None listed |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis Zee. 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.