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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)
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Top companies in OWB

DateFirm and productCodeLinked 510(k)
Apr 15, 2016Ziehm Imaging Inc
Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated
OWBK142740
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
OWBK123529
Mar 31, 2016Siemens Medical Solutions USA, Inc
Cios Alpha, mobile X-ray system
Terminated
OWBK132094
Mar 17, 2016Medtronic Navigation, Inc.-Littleton
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Terminated
OWBK151000
Mar 11, 2016Siemens Medical Solutions USA, Inc
Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obe
Terminated
OWBK133580
Mar 8, 2016Medtronic Navigation, Inc.
Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physi
Terminated
OWBK151000
Feb 24, 2016Regulatory Insight, Inc
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-va
Terminated
OWBK033486
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
OWBK123529
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
OWBK123529
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
OWBK123529
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
OWBK123529
Feb 16, 2016Siemens Medical Solutions USA, Inc
CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinica
Terminated
OWBK132094
Feb 9, 2016Toshiba American Medical Systems Inc
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Terminated
OWBK120073
K133535 +2
Feb 5, 2016Philips Electronics North America Corporation
Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
Terminated
OWBK102005
Feb 5, 2016Philips Electronics North America Corporation
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
Terminated
OWBK033737
Jan 30, 2016Philips Electronics North America Corporation
INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane sy
Terminated
OWBK002016
Jan 30, 2016Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS
Terminated
OWBK002016
Jan 30, 2016Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Al
Terminated
OWBK002016
Jan 30, 2016Philips Electronics North America Corporation
INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS All
Terminated
OWBK002016
Jan 30, 2016Philips Electronics North America Corporation
Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technici
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are quali
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cer
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, tho
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peri
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. periph
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral,
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, inter
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, intervention
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, ce
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, tho
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, tho
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent place
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent plac
Terminated
OWBK141979
Jan 30, 2016Philips Electronics North America Corporation
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional proc
Terminated
OWBK141979
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
OWBK073290
K123529
Dec 18, 2015GE Medical Systems, LLC
Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, I
Terminated
OWBK022322
K042053 +4
Oct 1, 2015Philips Electronics North America Corporation
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including d
Terminated
OWBK141979
Aug 18, 2015Siemens Medical Solutions USA, Inc
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Terminated
OWBK123529
Aug 17, 2015Siemens Medical Solutions USA, Inc
CIOS ALPHA; image intensified fluoroscopic x-ray system
Terminated
OWBK132094
Aug 5, 2015Siemens Medical Solutions USA, Inc
Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedure
Terminated
OWBK123529
Jul 20, 2015GE Healthcare
GE Healthcare Precision RXi Digital system
Terminated
OWBK082243
Jul 20, 2015GE Healthcare
GE Healthcare Precision RXi 23A/32A Analog System
Terminated
OWBK082243
Jul 3, 2015GE Healthcare
GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and im
Terminated
OWBK133278
Jul 2, 2015Siemens Medical Solutions USA, Inc
Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are n
Terminated
OWBK132094
Jun 25, 2015Siemens Medical Solutions USA, Inc
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includin
Terminated
OWBK141574
May 23, 2015Siemens Medical Solutions USA, Inc
SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general
Terminated
OWBK062623
Apr 14, 2015Siemens Medical Solutions USA, Inc
Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediat
Terminated
OWBK123529
Apr 6, 2015Toshiba American Medical Systems Inc
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is regi
Terminated
OWBK143225
Feb 17, 2015Siemens Medical Solutions USA, Inc
Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with t
Terminated
OWBK133580
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics
Terminated
OWBK033737
K041949 +2

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