510(k) K190768 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS icono
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Sep 12, 2019 |
| Received | Mar 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2023 | Siemens Medical Solutions USA, Inc ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor Open, Classified |
OWB | None listed |
| Apr 11, 2022 | Siemens Medical Solutions USA, Inc Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures
SMN: 11327600 Open, Classified |
OWB | None listed |
| Apr 11, 2022 | Siemens Medical Solutions USA, Inc Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures
SMN: 11327700 Open, Classified |
OWB | None listed |
| Feb 25, 2022 | Siemens Medical Solutions USA, Inc syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows:
(1) Artis pheno
Model Number:10849000
(2) Artis icono biplane
Model Number: Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.