ClearanceBrief
510(k) K073290 ยท IZI System, X-Ray, Angiographic

ARTIS ZEE AND ZEEGO

ApplicantSiemens Medical Solutions USA, Inc., Malvern PA, US
DecisionSubstantially Equivalent, Feb 11, 2008
ReceivedNov 21, 2007
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K073290

DateFirm and productCodeLinked 510(k)
Apr 9, 2019Siemens Medical Solutions USA, Inc
Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and i
Terminated
IZINone listed
Apr 9, 2019Siemens Medical Solutions USA, Inc
Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional proced
Terminated
IZINone listed
Oct 26, 2018Siemens Medical Solutions USA, Inc
Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including,
Terminated
IZINone listed
Oct 19, 2018Siemens Medical Solutions USA, Inc
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interv
Terminated
IZINone listed
Sep 28, 2017Siemens Medical Solutions USA, Inc
Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Terminated
OWBNone listed
Aug 24, 2017Siemens Medical Solutions USA, Inc
AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including,
Terminated
OWBNone listed
Jun 6, 2017Siemens Medical Solutions USA, Inc
Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354
Terminated
IZINone listed
Mar 30, 2017Siemens Medical Solutions USA, Inc
Artis zee, Angiographic x-ray system
Terminated
IZINone listed
Feb 27, 2017Siemens Medical Solutions USA, Inc
Artis Zee and Zeego fluoroscopic x-ray system
Terminated
IZINone listed
Feb 3, 2017Siemens Medical Solutions USA, Inc
Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limite
Terminated
IZINone listed
Jul 13, 2016Siemens Medical Solutions USA, Inc
ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and
Terminated
IZINone listed
Jul 7, 2016Siemens Medical Solutions USA, Inc
Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee /
Terminated
IZINone listed
Mar 31, 2016Siemens Medical Solutions USA, Inc
system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging
Terminated
IZINone listed
Mar 31, 2016Siemens Medical Solutions USA, Inc
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and inte
Terminated
IZINone listed
Feb 19, 2016Siemens Medical Solutions USA, Inc
Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operati
Terminated
IZINone listed
Feb 18, 2016Siemens Medical Solutions USA, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve
Terminated
IZINone listed
Feb 18, 2016Siemens Medical Solutions USA, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve
Terminated
IZINone listed
Feb 18, 2016Siemens Medical Solutions USA, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve
Terminated
IZINone listed
Feb 18, 2016Siemens Medical Solutions USA, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve
Terminated
IZINone listed
Feb 18, 2016Siemens Medical Solutions USA, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve
Terminated
IZINone listed
Feb 18, 2016Siemens Medical Solutions USA, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve
Terminated
IZINone listed
Feb 18, 2016Siemens Medical Solutions USA, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve
Terminated
IZINone listed
Feb 18, 2016Siemens Medical Solutions USA, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve
Terminated
IZINone listed
Dec 24, 2015Siemens Medical Solutions USA, Inc
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
Terminated
OWBNone listed
Aug 5, 2015Siemens Medical Solutions USA, Inc
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Terminated
IZINone listed
Jan 14, 2015Siemens Medical Solutions USA, Inc
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedu
Terminated
IZINone listed
Dec 1, 2014Siemens Medical Solutions USA, Inc
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
Terminated
IZINone listed
Nov 7, 2014Siemens Medical Solutions USA, Inc
Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedu
Terminated
IZINone listed
Sep 24, 2014Siemens Medical Solutions USA, Inc
AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures in
Terminated
IZINone listed
Sep 22, 2014Siemens Medical Solutions USA, Inc
Artis zee and Artis zeego systems. x-ray, angiographic system
Terminated
IZINone listed
Mar 31, 2014Siemens Medical Solutions USA, Inc
Artis Zee Angiographic x-ray systems.
Terminated
IZINone listed
Mar 22, 2014Siemens Medical Solutions USA, Inc
AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited
Terminated
IZINone listed
Feb 24, 2014Siemens Medical Solutions USA, Inc
Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
Terminated
IZINone listed
Jul 22, 2013Siemens Medical Solutions USA, Inc
ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
Terminated
IZINone listed
Mar 26, 2013Siemens Medical Solutions USA, Inc
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Terminated
IZINone listed
Aug 16, 2010Siemens Medical Solutions USA, Inc
AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system.
Terminated
IZINone listed
Dec 3, 2009Siemens Medical Solutions USA, Inc
Axiom Artis Zee Multi-purpose, Model number 10094139 angiographic x-ray systems
Terminated
IZINone listed
Jun 16, 2009Siemens Medical Solutions USA, Inc
Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 10281153 3-bulb surgery lamp, 115V.
Terminated
JAKNone listed
Nov 4, 2008Siemens Medical Solutions USA, Inc
Axiom Artis Zee. Angiographic X-ray System.
Terminated
IZINone listed

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