ClearanceBrief
Panels › Radiology › Product code OWB · Class 2

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)
Get daily alerts for OWBSample briefCSV

Top companies in OWB

DateFirm and productCodeLinked 510(k)
May 1, 2018Siemens Medical Solutions USA, Inc
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Terminated
OWBK163286
Mar 20, 2018Siemens 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
OWBK133580
Mar 14, 2018Philips 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
OWBK133292
Feb 24, 2018Philips 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
OWBK133292
K141979
Dec 29, 2017Toshiba American Medical Systems Inc
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
Terminated
OWBK133535
K170909
Dec 29, 2017Toshiba American Medical Systems Inc
INFX-8000C Fluoroscopic X-Ray Systems
Terminated
OWBK152697
Dec 20, 2017Philips 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
OWBK141979
Dec 18, 2017Philips 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
OWBK162148
Sep 30, 2017Medtronic 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
OWBK151000
Sep 28, 2017Siemens Medical Solutions USA, Inc
Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Terminated
OWBK010721
K021021 +1
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
OWBK073290
K090745 +2
Sep 28, 2017Siemens 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
OWBK123529
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
OWBK073290
K123529
Aug 22, 2017Siemens 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
OWBK133580
Jun 6, 2017Siemens Medical Solutions USA, Inc
Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
Terminated
OWBK052202
Jun 6, 2017Siemens Medical Solutions USA, Inc
Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355
Terminated
OWBK123529
Mar 30, 2017Barco 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
OWBNone listed
Mar 22, 2017Philips 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
OWBK031333
K033737 +2
Mar 22, 2017Philips 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
OWBNone listed
Mar 22, 2017Philips 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
OWBK031333
K133292 +1
Mar 19, 2017Siemens Medical Solutions USA, Inc
ARTIS Q, Interventional Fluroscopic x-ray system
Terminated
OWBK123529
Mar 15, 2017Toshiba 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
OWBK170832
Feb 27, 2017Siemens Medical Solutions USA, Inc
Axiom Artis fluoroscopic x-ray system
Terminated
OWBK052202
Feb 27, 2017Siemens Medical Solutions USA, Inc
Artis Q and Q.Zen fluoroscopic x-ray system
Terminated
OWBK123529
Feb 23, 2017Ziehm Imaging Inc
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Terminated
OWBK161976
Feb 1, 2017Toshiba American Medical Systems Inc
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Terminated
OWBK152785
Jan 20, 2017GE OEC Medical Systems, Inc
OEC 9900 Elite. MDL Numbers: D148942, D155043
Terminated
OWBK120613
K122234
Jan 20, 2017GE OEC Medical Systems, Inc
OEC 9800. MDL Numbers: D222250, D141598
Terminated
OWBK111551
K132027
Jan 20, 2017Philips 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
OWBK133292
Jan 20, 2017Philips 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
OWBK133292
Jan 20, 2017Philips 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
OWBK033737
Jan 9, 2017GE 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
OWBK111551
K132027
Dec 8, 2016Siemens 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
OWBK123529
Dec 8, 2016Siemens 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
OWBK141574
Nov 21, 2016GE Healthcare, LLC
Innova 2000
Terminated
OWBK022322
Nov 17, 2016Siemens 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
OWBK052202
Nov 17, 2016Siemens 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
OWBK141574
Nov 17, 2016Siemens 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
OWBK123529
Oct 11, 2016Medtronic 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
OWBK151000
Jul 22, 2016GE OEC Medical Systems, Inc
OEC 9800, fluoroscopic x-ray system
Terminated
OWBK021049
K022069 +3
Jul 22, 2016GE OEC Medical Systems, Inc
OEC UroView 2800, fluoroscopic x-ray system
Terminated
OWBK993687
Jul 18, 2016Toshiba 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
OWBK150967
Jul 7, 2016Philips 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
OWBK141979
Jul 7, 2016Philips 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
OWBK141979
Jun 23, 2016Philips Medical Systems Nederlands
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Terminated
OWBK141979
May 23, 2016GE Medical Systems, LLC
GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Terminated
OWBK133278
May 23, 2016GE Medical Systems, LLC
GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Terminated
OWBK113403
Apr 15, 2016Ziehm Imaging Inc
Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated
OWBK092438
Apr 15, 2016Ziehm Imaging Inc
Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated
OWBK061203
Apr 15, 2016Ziehm Imaging Inc
Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated
OWBK083545

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.