510(k) K163286 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS pheno
| Applicant | Siemens Medical Solution USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Mar 9, 2017 |
| Received | Nov 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2023 | Siemens Medical Solutions USA, Inc ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)-
Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Model: 108490 Open, Classified |
OWB | None listed |
| Mar 30, 2023 | Siemens Medical Solutions USA, Inc ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system.
Material # 10849000. Open, Classified |
OWB | None listed |
| Jan 13, 2023 | Siemens Medical Solutions USA, Inc ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor Open, Classified |
OWB | None listed |
| Oct 21, 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 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 |
| 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 |
| Apr 22, 2020 | Siemens Medical Solutions USA, Inc ARTIS Pheno - Interventional Fluoroscopic X-Ray System
Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventio Terminated |
OWB | None listed |
| Jan 24, 2020 | Siemens Medical Solutions USA, Inc ARTIS Pheno-Interventional Fluoroscopic X-Ray System
Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging Terminated |
OWB | None listed |
| Dec 20, 2019 | Siemens Medical Solutions USA, Inc Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis pheno-Interventional Fluoroscopic X-Ray System
Model Number: 10849000 Terminated |
OWB | None listed |
| Jul 29, 2018 | Siemens Medical Solutions USA, Inc ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000 Terminated |
OWB | None listed |
| Jun 22, 2018 | Siemens Medical Solutions USA, Inc ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System
Product Usage:
Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interven Terminated |
OWB | None listed |
| May 30, 2018 | Siemens Medical Solutions USA, Inc ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000 Terminated |
OWB | None listed |
| May 1, 2018 | Siemens Medical Solutions USA, Inc ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000 Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.