510(k) K221516 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS icono (Ceiling Configuration)
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jul 19, 2022 |
| Received | May 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221516
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Siemens Medical Solutions USA, Inc ARTIS icono ceiling. Model Number: 11328100. Open, Classified |
OWB | None listed |
| 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 |
| Dec 9, 2023 | Siemens Medical Solutions USA, Inc ARTIS icono (ceiling configuration), Fluoroscopic x-ray system;
Model no. 11328100 Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.