510(k) K201156 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS pheno (VE2)
| Applicant | Siemens Medical Solution USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jun 29, 2020 |
| Received | Apr 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201156
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2022 | Siemens Medical Solutions USA, Inc Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 Open, Classified |
JAA | None listed |
| Feb 25, 2022 | Siemens Medical Solutions USA, Inc Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures.
Model: 10849000 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 |
| Oct 12, 2021 | Siemens Medical Solutions USA, Inc Artis pheno with software VE20C- diagnostic imaging angiography system
Model: 10849000 Terminated |
OWB | None listed |
| May 27, 2021 | Siemens Medical Solutions USA, Inc ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Model: 10849000 Open, Classified |
OWB | None listed |
| Mar 19, 2021 | Siemens Medical Solutions USA, Inc Interventional Fluoroscopic X-Ray System
ARTIS icono biplane- 11327600
ARTIS icono floor- 11327700
ARTIS pheno- 10849000
ARTIS is a family of dedicated angiography systems developed for single and bi Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.