510(k) K230949 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS pheno (VE30A)
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Dec 15, 2023 |
| Received | Apr 4, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230949
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2026 | Siemens Medical Solutions USA, Inc ARTIS Pheno VE30A and VE40A, Model 10849000 Open, Classified |
OWB | None listed |
| Jun 27, 2025 | Siemens Medical Solutions USA, Inc 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. Proced Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.