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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)
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics,
Terminated
OWBK033737
K041949 +2
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, in
Terminated
OWBK033737
K041949 +2
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, inte
Terminated
OWBK033737
K041949 +2
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics
Terminated
OWBK033737
K041949 +2
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics,
Terminated
OWBK033737
K041949 +2
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, i
Terminated
OWBK033737
K041949 +2
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 BIPLA
Terminated
OWBK033737
K041949 +2
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Usage: The A
Terminated
OWBK033737
K041949 +2
Jan 14, 2015GE Healthcare
GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for ca
Terminated
OWBK113403
K133278
Jan 14, 2015Siemens Medical Solutions USA, Inc
Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single and biplane diagnostic imaging and interventional pr
Terminated
OWBK123529
Dec 16, 2014GE Healthcare, LLC
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
Terminated
OWBK052412
Dec 16, 2014GE Healthcare, LLC
Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic
Terminated
OWBK133278
Nov 7, 2014GE OEC Medical Systems, Inc
Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
Terminated
OWBK021049
K022069 +2
Nov 7, 2014GE OEC Medical Systems, Inc
OEC UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
Terminated
OWBK993687
Nov 7, 2014Philips Medical Systems, Inc.
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and n
Terminated
OWBK033737
Nov 7, 2014Philips Medical Systems, Inc.
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascula
Terminated
OWBK033737
Oct 9, 2014Philips Medical Systems, Inc.
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Terminated
OWBK002016
Sep 16, 2014Siemens Medical Solutions USA, Inc
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a d
Terminated
OWBK062623
Jun 4, 2014Siemens Medical Solutions USA, Inc
AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform
Terminated
OWBK062623
Apr 16, 2014GE OEC Medical Systems, Inc
The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventiona
Terminated
OWBK061953
K073543 +1
Mar 27, 2014Siemens Medical Solutions USA, Inc
Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
Terminated
OWBK123529
Mar 10, 2014GE Healthcare, LLC
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version
Terminated
OWBK023178
K031637 +3
Feb 3, 2014GE Healthcare, LLC
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic
Terminated
OWBK033486
K081091 +1
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated
OWBK083545
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated
OWBK061203
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated
OWBNone listed
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated
OWBK073346
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated
OWBK073346
Dec 24, 2013Ziehm Imaging Inc
Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated
OWBK092438
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated
OWBK851031
Nov 1, 2013Siemens Medical Solutions USA, Inc
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
Terminated
OWBK062623
K081722 +1
Oct 17, 2013GE Healthcare, LLC
GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
Terminated
OWBK022322
K023178 +4
Sep 18, 2013GE Healthcare, LLC
GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiova
Terminated
OWBK113403
Aug 1, 2013Siemens Medical Solutions USA, Inc
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Terminated
OWBK062623
Jul 18, 2013Leibel-Flarsheim Company LLC
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Terminated
OWBK943581
Jun 28, 2013GE Healthcare, LLC
GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is inten
Terminated
OWBK033244
K042053 +3
May 14, 2013GE Healthcare, LLC
GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and
Terminated
OWBK042053
K050489 +3
Apr 18, 2013GE Healthcare, LLC
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
Terminated
OWBK033244
K042053 +3

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