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) |
|---|---|---|---|
| Feb 3, 2015 | Philips 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 |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips 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 |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips 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 |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips 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 |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips 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 |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips 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 |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips 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 |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips 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 |
OWB | K033737 K041949 +2 |
| Jan 14, 2015 | GE 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 |
OWB | K113403 K133278 |
| Jan 14, 2015 | Siemens 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 |
OWB | K123529 |
| Dec 16, 2014 | GE 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 |
OWB | K052412 |
| Dec 16, 2014 | GE 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 |
OWB | K133278 |
| Nov 7, 2014 | GE 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 |
OWB | K021049 K022069 +2 |
| Nov 7, 2014 | GE 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 |
OWB | K993687 |
| Nov 7, 2014 | Philips 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 |
OWB | K033737 |
| Nov 7, 2014 | Philips 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 |
OWB | K033737 |
| Oct 9, 2014 | Philips Medical Systems, Inc. Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system Terminated |
OWB | K002016 |
| Sep 16, 2014 | Siemens 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 |
OWB | K062623 |
| Jun 4, 2014 | Siemens 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 |
OWB | K062623 |
| Apr 16, 2014 | GE 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 |
OWB | K061953 K073543 +1 |
| Mar 27, 2014 | Siemens Medical Solutions USA, Inc Siemens Artis Q and Artis Q biplane systems
Product Usage: Interventional Fluoroscopic X-ray Terminated |
OWB | K123529 |
| Mar 10, 2014 | GE 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 |
OWB | K023178 K031637 +3 |
| Feb 3, 2014 | GE 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 |
OWB | K033486 K081091 +1 |
| Dec 24, 2013 | Ziehm Imaging Inc Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System.
Mobile Fluoroscopic Imaging Terminated |
OWB | K083545 |
| Dec 24, 2013 | Ziehm Imaging Inc Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System.
Mobile Fluoroscopic Imaging Terminated |
OWB | K061203 |
| Dec 24, 2013 | Ziehm Imaging Inc Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System.
Mobile Fluoroscopic Imaging Terminated |
OWB | None listed |
| Dec 24, 2013 | Ziehm Imaging Inc Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System.
Mobile Fluoroscopic Imaging Terminated |
OWB | K073346 |
| Dec 24, 2013 | Ziehm Imaging Inc Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System.
Mobile Fluoroscopic Imaging Terminated |
OWB | K073346 |
| Dec 24, 2013 | Ziehm Imaging Inc Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System.
Mobile Fluoroscopic Imaging Terminated |
OWB | K092438 |
| Dec 24, 2013 | Ziehm Imaging Inc Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System.
Mobile Fluoroscopic Imaging Terminated |
OWB | K851031 |
| Nov 1, 2013 | Siemens 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 |
OWB | K062623 K081722 +1 |
| Oct 17, 2013 | GE 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 |
OWB | K022322 K023178 +4 |
| Sep 18, 2013 | GE 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 |
OWB | K113403 |
| Aug 1, 2013 | Siemens Medical Solutions USA, Inc Siemens Luminos dRF Fluoroscopic X-Ray system
Fluoroscopic X-Ray system Terminated |
OWB | K062623 |
| Jul 18, 2013 | Leibel-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 |
OWB | K943581 |
| Jun 28, 2013 | GE 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 |
OWB | K033244 K042053 +3 |
| May 14, 2013 | GE 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 |
OWB | K042053 K050489 +3 |
| Apr 18, 2013 | GE Healthcare, LLC GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ,
Cardiovascular and Interventional Imaging System. Terminated |
OWB | K033244 K042053 +3 |
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