510(k) K193326 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS Icono
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Apr 16, 2020 |
| Received | Dec 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193326
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2022 | Siemens Medical Solutions USA, Inc Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 Open, Classified |
JAK | 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 Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures.
Model: 11327600 Open, Classified |
OWB | None listed |
| Feb 25, 2022 | Siemens Medical Solutions USA, Inc Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures.
Model: 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 |
| Oct 12, 2021 | Siemens Medical Solutions USA, Inc Artis icono biplane with software VE20C-diagnostic imaging angiography system
Model: 11327600 Terminated |
OWB | None listed |
| Oct 12, 2021 | Siemens Medical Solutions USA, Inc Artis icono floor with software VE20C-diagnostic imaging angiography system
Model: 11327700 Terminated |
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 |
| Feb 26, 2021 | Siemens Medical Solutions USA, Inc Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Terminated |
OWB | None listed |
| Dec 18, 2020 | Siemens Medical Solutions USA, Inc ARTIS Icono biplane Model:11327600
ARTIS Icono floor system Model: 11327700
with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedur Terminated |
OWB | None listed |
| Nov 4, 2020 | Siemens Medical Solutions USA, Inc ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervent Terminated |
OWB | None listed |
| Apr 23, 2020 | Siemens Medical Solutions USA, Inc ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System
Model Number: 11327600 Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.