Interventional Fluoroscopic X-Ray System
Regulation 892.1650
18510(k)s in 12 months (325 all time)
110recalls in 12 months (638 all time)
607recalls that name a 510(k)
Top companies in OWB
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2018 | Siemens Medical Solutions USA, Inc ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000 Terminated |
OWB | K163286 |
| Mar 20, 2018 | Siemens Medical Solutions USA, Inc Artis one fluoroscopic x-ray system and patient table
Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and o Terminated |
OWB | K133580 |
| Mar 14, 2018 | Philips Electronics North America Corporation Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system
Product Usage:
The Allura Xper ED series is intended for use on human pa Terminated |
OWB | K133292 |
| Feb 24, 2018 | Philips Electronics North America Corporation Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage.
Product Usage:
The Allura Xper series is intended for use on human patients to perform: Vascular Terminated |
OWB | K133292 K141979 |
| Dec 29, 2017 | Toshiba American Medical Systems Inc INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM Terminated |
OWB | K133535 K170909 |
| Dec 29, 2017 | Toshiba American Medical Systems Inc INFX-8000C Fluoroscopic X-Ray Systems Terminated |
OWB | K152697 |
| Dec 20, 2017 | Philips Electronics North America Corporation Allura Xper FD and and Xper FD ORT - Philips X-ray Systems
Product Usage:
The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, inclu Terminated |
OWB | K141979 |
| Dec 18, 2017 | Philips Electronics North America Corporation Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20
The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neuro Terminated |
OWB | K162148 |
| Sep 30, 2017 | Medtronic Navigation, Inc.-Littleton O-arm O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatri Terminated |
OWB | K151000 |
| Sep 28, 2017 | Siemens Medical Solutions USA, Inc Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813. Terminated |
OWB | K010721 K021021 +1 |
| Sep 28, 2017 | Siemens Medical Solutions USA, Inc Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813. Terminated |
OWB | K073290 K090745 +2 |
| Sep 28, 2017 | Siemens Medical Solutions USA, Inc Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813. Terminated |
OWB | K123529 |
| Aug 24, 2017 | Siemens 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 |
OWB | K073290 K123529 |
| Aug 22, 2017 | Siemens Medical Solutions USA, INC Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional pro Terminated |
OWB | K133580 |
| Jun 6, 2017 | Siemens Medical Solutions USA, Inc Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392 Terminated |
OWB | K052202 |
| Jun 6, 2017 | Siemens Medical Solutions USA, Inc Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355 Terminated |
OWB | K123529 |
| Mar 30, 2017 | Barco N.V. Optional MDRC-1119 Front Cover Attachment Kit for review display monitors.
Product Usage:
The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC- Terminated |
OWB | None listed |
| Mar 22, 2017 | Philips Electronics North America Corporation The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 Terminated |
OWB | K031333 K033737 +2 |
| Mar 22, 2017 | Philips Electronics North America Corporation UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 bipla Terminated |
OWB | None listed |
| Mar 22, 2017 | Philips Electronics North America Corporation Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10 Terminated |
OWB | K031333 K133292 +1 |
| Mar 19, 2017 | Siemens Medical Solutions USA, Inc ARTIS Q, Interventional Fluroscopic x-ray system Terminated |
OWB | K123529 |
| Mar 15, 2017 | Toshiba American Medical Systems Inc Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80
Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. Terminated |
OWB | K170832 |
| Feb 27, 2017 | Siemens Medical Solutions USA, Inc Axiom Artis fluoroscopic x-ray system Terminated |
OWB | K052202 |
| Feb 27, 2017 | Siemens Medical Solutions USA, Inc Artis Q and Q.Zen fluoroscopic x-ray system Terminated |
OWB | K123529 |
| Feb 23, 2017 | Ziehm Imaging Inc Ziehm Imaging solo FD Mobile Fluoroscopic C-arm Terminated |
OWB | K161976 |
| Feb 1, 2017 | Toshiba American Medical Systems Inc Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F Terminated |
OWB | K152785 |
| Jan 20, 2017 | GE OEC Medical Systems, Inc OEC 9900 Elite. MDL Numbers: D148942, D155043 Terminated |
OWB | K120613 K122234 |
| Jan 20, 2017 | GE OEC Medical Systems, Inc OEC 9800. MDL Numbers: D222250, D141598 Terminated |
OWB | K111551 K132027 |
| Jan 20, 2017 | Philips Electronics North America Corporation Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomie Terminated |
OWB | K133292 |
| Jan 20, 2017 | Philips Electronics North America Corporation Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), Terminated |
OWB | K133292 |
| Jan 20, 2017 | Philips Electronics North America Corporation Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pace Terminated |
OWB | K033737 |
| Jan 9, 2017 | GE OEC Medical Systems, Inc OEC 9800. MDL Numbers: D222250, D141598
The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applic Terminated |
OWB | K111551 K132027 |
| Dec 8, 2016 | Siemens Medical Solutions USA, Inc Artis Q/Q.zen, Angiographic x-ray system
Stand alone system
The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional proc Terminated |
OWB | K123529 |
| Dec 8, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego, Angiographic x-ray system
Stand alone system
The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional pro Terminated |
OWB | K141574 |
| Nov 21, 2016 | GE Healthcare, LLC Innova 2000 Terminated |
OWB | K022322 |
| Nov 17, 2016 | Siemens Medical Solutions USA, Inc AXIOM Artis, Angiographic x-ray system
Product Usage:
The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedure Terminated |
OWB | K052202 |
| Nov 17, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego, Angiographic x-ray system
Product Usage:
The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional proced Terminated |
OWB | K141574 |
| Nov 17, 2016 | Siemens Medical Solutions USA, Inc Artis Q, Angiographic x-ray system
Product Usage:
The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures inc Terminated |
OWB | K123529 |
| Oct 11, 2016 | Medtronic Navigation, Inc.-Littleton Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000
Product Usage:
The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is de Terminated |
OWB | K151000 |
| Jul 22, 2016 | GE OEC Medical Systems, Inc OEC 9800, fluoroscopic x-ray system Terminated |
OWB | K021049 K022069 +3 |
| Jul 22, 2016 | GE OEC Medical Systems, Inc OEC UroView 2800, fluoroscopic x-ray system Terminated |
OWB | K993687 |
| Jul 18, 2016 | Toshiba American Medical Systems Inc Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System Terminated |
OWB | K150967 |
| Jul 7, 2016 | Philips Electronics North America Corporation UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table, 722034; UNIQ FD20 OR Table, 722035; UNIQ FD20/2 Terminated |
OWB | K141979 |
| Jul 7, 2016 | Philips Electronics North America Corporation Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029;
Allura Xper FD10 OR Table, 722033; Allura Xper Terminated |
OWB | K141979 |
| Jun 23, 2016 | Philips Medical Systems Nederlands Philips Allura Xper System: Interventional Fluoroscopic X-Ray System
Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058. Terminated |
OWB | K141979 |
| May 23, 2016 | GE Medical Systems, LLC GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy. Terminated |
OWB | K133278 |
| May 23, 2016 | GE Medical Systems, LLC GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy. Terminated |
OWB | K113403 |
| Apr 15, 2016 | Ziehm Imaging Inc Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging Terminated |
OWB | K092438 |
| Apr 15, 2016 | Ziehm Imaging Inc Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging Terminated |
OWB | K061203 |
| Apr 15, 2016 | Ziehm Imaging Inc Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging Terminated |
OWB | K083545 |
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