510(k) K141574 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS ZEE/ZEEGO SW VC21
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Sep 5, 2014 |
| Received | Jun 12, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141574
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2018 | Siemens Medical Solutions USA, Inc Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures. Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zeego, Material no. 10280959
, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | 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 |
| Dec 8, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego, 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 pro Terminated |
OWB | None listed |
| Nov 17, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego, 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 proced Terminated |
OWB | None listed |
| Jun 25, 2015 | Siemens Medical Solutions USA, Inc Artis zee/ zeego systems;
Product Usage: Usage:
Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includin Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.