510(k) K123529 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Feb 26, 2013 |
| Received | Nov 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123529
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2019 | Siemens Medical Solutions USA, Inc Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and inter Terminated |
IZI | None listed |
| Apr 9, 2019 | Siemens Medical Solutions USA, Inc Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and inter Terminated |
IZI | None listed |
| Oct 19, 2018 | Siemens Medical Solutions USA, Inc ARTIS Q biplane with Material 10848282-
- a Angiographic x-ray system
Product Usage:
Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional Terminated |
OWB | None listed |
| Oct 19, 2018 | Siemens Medical Solutions USA, Inc ARTIS Q.zen biplane with Material 10848355
- a Angiographic x-ray system
Product Usage:
Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventio Terminated |
OWB | None listed |
| Jul 29, 2018 | Siemens Medical Solutions USA, Inc Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355 Terminated |
OWB | None listed |
| Jun 22, 2018 | Siemens Medical Solutions USA, Inc Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355
Product Usage:
Artis is a family of dedicated angiography systems developed for single and b Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | None listed |
| Sep 28, 2017 | Siemens Medical Solutions USA, Inc Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless 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 Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355 Terminated |
OWB | None listed |
| Mar 19, 2017 | Siemens Medical Solutions USA, Inc ARTIS Q, Interventional Fluroscopic x-ray system Terminated |
OWB | None listed |
| Feb 27, 2017 | Siemens Medical Solutions USA, Inc Artis Q and Q.Zen fluoroscopic x-ray system Terminated |
OWB | None listed |
| Dec 8, 2016 | Siemens Medical Solutions USA, Inc Artis Q/Q.zen, Angiographic x-ray system
Stand alone system
The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional proc Terminated |
OWB | None listed |
| Nov 17, 2016 | Siemens Medical Solutions USA, Inc Artis Q, 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 procedures inc Terminated |
OWB | None listed |
| Jul 13, 2016 | Siemens Medical Solutions USA, Inc ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22
AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed 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 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 |
OWB | 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 |
OWB | 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 |
OWB | 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 |
OWB | 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 |
OWB | 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 18, 2015 | Siemens Medical Solutions USA, Inc Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Terminated |
OWB | None listed |
| Aug 5, 2015 | Siemens Medical Solutions USA, Inc Artis Q systems;
dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedure Terminated |
OWB | None listed |
| Apr 14, 2015 | Siemens Medical Solutions USA, Inc Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediat Terminated |
OWB | None listed |
| Jan 14, 2015 | Siemens Medical Solutions USA, Inc Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single and biplane diagnostic imaging and interventional pr Terminated |
OWB | None listed |
| Mar 27, 2014 | Siemens Medical Solutions USA, Inc Siemens Artis Q and Artis Q biplane systems
Product Usage: Interventional Fluoroscopic X-ray Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.