510(k) K241572 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 22, 2024 |
| Received | May 31, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241572
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Siemens Medical Solutions USA, Inc ARTIS icono biplane. Model Number: 11327600. Open, Classified |
OWB | None listed |
| Jul 1, 2026 | Siemens Medical Solutions USA, Inc ARTIS icono ceiling. Model Number: 11328100. Open, Classified |
OWB | None listed |
| Jul 1, 2026 | Siemens Medical Solutions USA, Inc ARTIS icono floor. Model Number: 11327700. Open, Classified |
OWB | None listed |
| Jun 4, 2026 | Siemens Medical Solutions USA, Inc ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system Open, Classified |
OWB | None listed |
| Jun 4, 2026 | Siemens Medical Solutions USA, Inc ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system Open, Classified |
OWB | None listed |
| Apr 16, 2026 | Siemens Medical Solutions USA, Inc ARTIS Pheno VE30A and VE40A, Model 10849000 Open, Classified |
OWB | None listed |
| Apr 7, 2026 | Siemens Medical Solutions USA, Inc ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. Open, Classified |
OWB | None listed |
| Sep 5, 2025 | Siemens Medical Solutions USA, Inc Artis Pheno. Image-Intensified Flouroscopic X-Ray System. Open, Classified |
OWB | None listed |
| Jun 27, 2025 | Siemens Medical Solutions USA, Inc interventional fluoroscopic x-ray system Open, Classified |
OWB | None listed |
| Jun 27, 2025 | Siemens Medical Solutions USA, Inc interventional fluoroscopic x-ray system Open, Classified |
OWB | None listed |
| Jun 27, 2025 | Siemens Medical Solutions USA, Inc interventional fluoroscopic x-ray system Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.