510(k) K181407 ยท OWB Interventional Fluoroscopic X-Ray System
Artis zee/zeego & Artis Q/Q.zen
| Applicant | Siemens Medical Solution USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Aug 15, 2018 |
| Received | May 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181407
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2024 | Siemens Medical Solutions USA, Inc Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models:
Artis zee floor- 10094135
Artis zee ceiling- 10094137
Artis zee multi-purpose- 10094139
Artis zee biplane- 10094141
Artis zeego- Open, Classified |
OWB | None listed |
| Jan 30, 2023 | Siemens Medical Solutions USA, Inc System Material #
Artis zee floor 10094135
Artis zee ceiling 10094137
Artis zee multi-purpose 10094139
Artis zee biplane 10094141
Artis zeego 10280959
Artis Q floor 10848280
Artis Q ceiling 10848281 Open, Classified |
OWB | None listed |
| Aug 26, 2022 | Siemens Medical Solutions USA, Inc Artis Q floor- Model No. 10848280
Artis Q ceiling- Model No. 10848281
Artis Q biplane- Model No. 10848282
Artis Q zeego- Model No. 10848283
Artis Q.zen floor- Model No. 10848353
Artis Q.zen ceiling- M Open, Classified |
JAK | None listed |
| May 24, 2022 | Siemens Medical Solutions USA, Inc Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System Terminated |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee floor, Model Number 10094135 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee ceiling, Model Number 10094137 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee multi-purpose, Model Number 10094139 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee biplane, Model Number 10094141 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee floor MN, Model Number 10094142 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee biplane MN, Model Number 10094143 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zeego, Model Number 10280959 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q floor, Model Number 10848280 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q ceiling, Model Number 10848281 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q biplane, Model Number 10848282 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q zeego, Model Number 10848283 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q.zen floor, Model Number 10848353 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q.zen ceiling, Model Number 10848354 Open, Classified |
OWB | None listed |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q.zen biplane, Model Number 10848355 Open, Classified |
OWB | None listed |
| Oct 20, 2021 | Siemens Medical Solutions USA, Inc Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number: 10094135 Terminated |
OWB | None listed |
| Oct 20, 2021 | Siemens Medical Solutions USA, Inc Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number:10094137 Terminated |
OWB | None listed |
| Oct 20, 2021 | Siemens Medical Solutions USA, Inc Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number: 10094139 Terminated |
OWB | None listed |
| Oct 20, 2021 | Siemens Medical Solutions USA, Inc Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number: 10094141 Terminated |
OWB | None listed |
| Oct 20, 2021 | Siemens Medical Solutions USA, Inc Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number: 10848280 Terminated |
OWB | None listed |
| Oct 20, 2021 | Siemens Medical Solutions USA, Inc Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number: 10848281 Terminated |
OWB | None listed |
| Oct 20, 2021 | Siemens Medical Solutions USA, Inc Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number: 10848282 Terminated |
OWB | None listed |
| Oct 20, 2021 | Siemens Medical Solutions USA, Inc Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number: 10848353 Terminated |
OWB | None listed |
| Oct 20, 2021 | Siemens Medical Solutions USA, Inc Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number: 10848354 Terminated |
OWB | None listed |
| Oct 20, 2021 | Siemens Medical Solutions USA, Inc Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number:10848355 Terminated |
OWB | None listed |
| Sep 24, 2021 | Siemens Medical Solutions USA, Inc Artis zeego, Fluoroscopic X-Ray System
Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models:
Product/Model #:
syngo X Workplace, 10281061
Open, Classified |
OWB | None listed |
| Jun 30, 2021 | Siemens Medical Solutions USA, Inc Artis Models with SW version VD12 listed below:
Artis zee floor 10094135
Artis zee ceiling 10094137
Artis zee MP 10094139
Artis Q floor 10848280
Artis Q ceiling 10848281
Artis Q biplane 10848282 Terminated |
OWB | None listed |
| Mar 30, 2021 | Siemens Medical Solutions USA, Inc Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Mod Terminated |
OWB | None listed |
| Mar 26, 2021 | Siemens Medical Solutions USA, Inc Artis zee ceiling-interventional Fluoroscopic X-Ray System
Model Number: 10094137 Open, Classified |
OWB | None listed |
| Nov 30, 2020 | Siemens Medical Solutions USA, Inc Artis zee/ zeego & Artis Q/ Q.zen
Artis Pheno Open, Classified |
OWB | None listed |
| Oct 21, 2020 | Siemens Medical Solutions USA, Inc Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedica Terminated |
OWB | None listed |
| Aug 3, 2020 | Siemens Medical Solutions USA, Inc Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures.
System Name/Material Number:
Artis Q BIPLANE 10848282
ARTIS Q CEI Terminated |
OWB | None listed |
| Apr 30, 2020 | Siemens Medical Solutions USA, Inc Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows:
Artis Q floor Model: 10848280;
Artis Q ceiling Model: 10848281;
Artis Q biplane Model:1084 Terminated |
OWB | None listed |
| Mar 13, 2020 | Siemens Medical Solutions USA, Inc Artis Q Biplane, Model No. 10848282;
Artis Q Ceiling, Model No.10848281;
Artis Q Floor, Model No. 10848280;
Artis Q zeego, Model No. 10848283
Product Usage: Artis is a family of dedicated angiography Terminated |
OWB | None listed |
| Mar 13, 2020 | Siemens Medical Solutions USA, Inc Artis Q.zen Biplane, Model No. 10848355
Artis Q.zen Ceiling, Model No. 10848354
Artis Q.zen Floor, Model No. 10848353
Product Usage: Artis is a family of dedicated angiography systems developed for si Terminated |
OWB | None listed |
| Mar 13, 2020 | Siemens Medical Solutions USA, Inc Artis zee Biplane, Model No. 10094141;
Artis zee Ceiling, Model No. 10094137;
Artis zee Floor, Model No. 10094135;
Artis zeego, Model No. 10280959
Product Usage: Artis is a family of dedicated angiogr Terminated |
OWB | None listed |
| Nov 14, 2019 | Siemens Medical Solutions USA, Inc Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C Terminated |
OWB | None listed |
| Jul 30, 2019 | Siemens Medical Solutions USA, Inc Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows:
Systems Material Number
Artis zee biplane 10094141;
Artis Q floor Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee floor, Model Number 10094135 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee ceiling, Model Number 10094137 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee multi, Model Number 10094139 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee biplane, Model Number 10094141 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee floor MN, Model Number 10094142 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee biplane MN, Model Number 10094143 Terminated |
OWB | None listed |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zeego, Model Number 10280959 Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System
Model Number: 10094135 Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System
Model Number: 10094137 Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System
Model Number: 10094141 Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis zeego--Interventional Fluoroscopic X-Ray System
Model Number: 10280959 Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System
Model Number: 10848280 Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System
Model Number: 10848281 Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System
Model Number: 10848282 Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System
Model Number: 10848283 Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System
Model Number: 10848353 Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System
Model Number: 10848354 Terminated |
OWB | None listed |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System
Model Number: 10848355 Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.