510(k) K021021 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
| Applicant | Siemens Medical Solutions USA, Inc., Iselin NJ, US |
| Decision | Substantially Equivalent, Jun 6, 2002 |
| Received | Mar 29, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021021
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2018 | Siemens Medical Solutions USA, Inc AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures. Terminated |
JAA | None listed |
| Mar 20, 2018 | Siemens Medical Solutions USA, Inc AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and inter Terminated |
JAA | None listed |
| 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 |
| Feb 19, 2016 | Siemens Medical Solutions USA, Inc AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating r Terminated |
JAA | None listed |
| Aug 28, 2013 | Siemens Medical Solutions USA, Inc Axiom Artis systems. C-arm angiographic x-ray system
x-ray, angiographic system. Terminated |
IZI | None listed |
| Oct 26, 2010 | Siemens Medical Solutions USA, Inc AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755
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 |
| May 28, 2010 | Siemens Medical Solutions USA, Inc Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355.
Intended for x-ray, angiographic use. Terminated |
MQB | None listed |
| Apr 8, 2010 | Siemens Medical Solutions USA, Inc Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, and 7728392.
Intended use: Angiographic x-ray system. Terminated |
IZI | None listed |
| Apr 5, 2010 | Siemens Medical Solutions USA, Inc Axiom Artis Systems operating with A100 Generator Terminated |
MQB | None listed |
| Dec 3, 2009 | Siemens Medical Solutions USA, Inc Axiom Artis dMP, Model number 7555365
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 10281150 Surgery lamp, 230V. Terminated |
JAA | 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.