ClearanceBrief
510(k) K181407 ยท OWB Interventional Fluoroscopic X-Ray System

Artis zee/zeego & Artis Q/Q.zen

ApplicantSiemens Medical Solution USA, Inc., Malvern PA, US
DecisionSubstantially Equivalent, Aug 15, 2018
ReceivedMay 30, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K181407

DateFirm and productCodeLinked 510(k)
Apr 18, 2024Siemens 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
OWBNone listed
Jan 30, 2023Siemens 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
OWBNone listed
Aug 26, 2022Siemens 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
JAKNone listed
May 24, 2022Siemens Medical Solutions USA, Inc
Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
Terminated
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee floor, Model Number 10094135
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee ceiling, Model Number 10094137
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee multi-purpose, Model Number 10094139
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee biplane, Model Number 10094141
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee floor MN, Model Number 10094142
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee biplane MN, Model Number 10094143
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zeego, Model Number 10280959
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q floor, Model Number 10848280
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q ceiling, Model Number 10848281
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q biplane, Model Number 10848282
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q zeego, Model Number 10848283
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q.zen floor, Model Number 10848353
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q.zen ceiling, Model Number 10848354
Open, Classified
OWBNone listed
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q.zen biplane, Model Number 10848355
Open, Classified
OWBNone listed
Oct 20, 2021Siemens 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
OWBNone listed
Oct 20, 2021Siemens 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
OWBNone listed
Oct 20, 2021Siemens 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
OWBNone listed
Oct 20, 2021Siemens 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
OWBNone listed
Oct 20, 2021Siemens 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
OWBNone listed
Oct 20, 2021Siemens 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
OWBNone listed
Oct 20, 2021Siemens 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
OWBNone listed
Oct 20, 2021Siemens 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
OWBNone listed
Oct 20, 2021Siemens 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
OWBNone listed
Oct 20, 2021Siemens 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
OWBNone listed
Sep 24, 2021Siemens 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
OWBNone listed
Jun 30, 2021Siemens 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
OWBNone listed
Mar 30, 2021Siemens 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
OWBNone listed
Mar 26, 2021Siemens Medical Solutions USA, Inc
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Open, Classified
OWBNone listed
Nov 30, 2020Siemens Medical Solutions USA, Inc
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Open, Classified
OWBNone listed
Oct 21, 2020Siemens 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
OWBNone listed
Aug 3, 2020Siemens 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
OWBNone listed
Apr 30, 2020Siemens 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
OWBNone listed
Mar 13, 2020Siemens 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
OWBNone listed
Mar 13, 2020Siemens 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
OWBNone listed
Mar 13, 2020Siemens 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
OWBNone listed
Nov 14, 2019Siemens Medical Solutions USA, Inc
Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
Terminated
OWBNone listed
Jul 30, 2019Siemens 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
OWBNone listed
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee floor, Model Number 10094135
Terminated
OWBNone listed
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee ceiling, Model Number 10094137
Terminated
OWBNone listed
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee multi, Model Number 10094139
Terminated
OWBNone listed
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee biplane, Model Number 10094141
Terminated
OWBNone listed
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee floor MN, Model Number 10094142
Terminated
OWBNone listed
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee biplane MN, Model Number 10094143
Terminated
OWBNone listed
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zeego, Model Number 10280959
Terminated
OWBNone listed
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
Terminated
OWBNone listed
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
Terminated
OWBNone listed
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
Terminated
OWBNone listed
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
Terminated
OWBNone listed
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
Terminated
OWBNone listed
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
Terminated
OWBNone listed
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
Terminated
OWBNone listed
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283
Terminated
OWBNone listed
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
Terminated
OWBNone listed
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
Terminated
OWBNone listed
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
Terminated
OWBNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.