510(k) K220432 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS icono (VE21) System
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jun 29, 2022 |
| Received | Feb 15, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220432
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2024 | Siemens AG/Siemens Healthcare GmbH ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Open, Classified |
OWB | None listed |
| Aug 8, 2023 | Siemens Medical Solutions USA, Inc ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Material Number: 11327600 Open, Classified |
OWB | None listed |
| Aug 8, 2023 | Siemens Medical Solutions USA, Inc ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Material Number: 11327700 Open, Classified |
OWB | None listed |
| Aug 26, 2022 | Siemens Medical Solutions USA, Inc Artis icono biplane- Model No. 11327600
Artis icono floor- Model No. 11327700 Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.