510(k) K220409 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS pheno (VE21) System
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jun 29, 2022 |
| Received | Feb 14, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220409
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2023 | Siemens Medical Solutions USA, Inc ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Material Number: 10849000 Open, Classified |
OWB | None listed |
| Aug 26, 2022 | Siemens Medical Solutions USA, Inc Artis pheno- Model No. 10849000 Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.