510(k) K052202 ยท OWB Interventional Fluoroscopic X-Ray System
AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Mar 7, 2006 |
| Received | Aug 12, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052202
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2021 | Siemens Medical Solutions USA, Inc Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Mod Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis FC, Model Number 5904433 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis FA, Model Number 5904441 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis MP, Model Number 5904466 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis BC, Model Number 5904649 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis BA, Model Number 5904656 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dBC, Model Number 5917054 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis TA, Model Number 7007755 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dTA, Model Number 7008605 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dFC, Model Number 7412807 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dTC, Model Number 7413078 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dBA, Model Number 7555357 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dMP, Model Number 7555365 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dFA, Model Number 7555373 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dFC, Model Number 7727717 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis TC, Model Number 7728350 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dBC, Model Number 7728392 Terminated |
OWB | 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 |
| Jun 6, 2017 | Siemens Medical Solutions USA, Inc Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392 Terminated |
OWB | None listed |
| Feb 27, 2017 | Siemens Medical Solutions USA, Inc Axiom Artis fluoroscopic x-ray system Terminated |
OWB | None listed |
| Nov 17, 2016 | Siemens Medical Solutions USA, Inc AXIOM Artis, Angiographic x-ray system
Product Usage:
The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedure Terminated |
OWB | None listed |
| Jan 27, 2012 | Siemens Medical Solutions USA, Inc AXIOM Artis and AXIOM Artis zee modular angiographic systems
Product Usage: Angiographic x-ray systems Terminated |
JAA | 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 10281151 Surgery lamp, 115V. Terminated |
JAA | None listed |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dFC using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | None listed |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dBA using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | None listed |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dFA using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | None listed |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dTC using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | None listed |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dTA using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | None listed |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dMP using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.