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) |
|---|---|---|---|
| Apr 15, 2016 | Ziehm Imaging Inc Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging Terminated |
OWB | K142740 |
| Mar 31, 2016 | Siemens 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 |
OWB | K123529 |
| Mar 31, 2016 | Siemens Medical Solutions USA, Inc Cios Alpha, mobile X-ray system Terminated |
OWB | K132094 |
| Mar 17, 2016 | Medtronic Navigation, Inc.-Littleton Medtronic Navigation O-arm 02 surgical x-ray imaging system Terminated |
OWB | K151000 |
| Mar 11, 2016 | Siemens 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 |
OWB | K133580 |
| Mar 8, 2016 | Medtronic 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 |
OWB | K151000 |
| Feb 24, 2016 | Regulatory 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 |
OWB | K033486 |
| Feb 18, 2016 | Siemens 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 |
OWB | K123529 |
| Feb 18, 2016 | Siemens 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 |
OWB | K123529 |
| Feb 18, 2016 | Siemens 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 |
OWB | K123529 |
| Feb 18, 2016 | Siemens 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 |
OWB | K123529 |
| Feb 16, 2016 | Siemens 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 |
OWB | K132094 |
| Feb 9, 2016 | Toshiba American Medical Systems Inc INFX-8000V Bi-Plane X-Ray Interventional System
X-ray systems Terminated |
OWB | K120073 K133535 +2 |
| Feb 5, 2016 | Philips Electronics North America Corporation Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications. Terminated |
OWB | K102005 |
| Feb 5, 2016 | Philips Electronics North America Corporation Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications. Terminated |
OWB | K033737 |
| Jan 30, 2016 | Philips 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 |
OWB | K002016 |
| Jan 30, 2016 | Philips 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 |
OWB | K002016 |
| Jan 30, 2016 | Philips 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 |
OWB | K002016 |
| Jan 30, 2016 | Philips 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 |
OWB | K002016 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Jan 30, 2016 | Philips 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 |
OWB | K141979 |
| Dec 24, 2015 | Siemens Medical Solutions USA, Inc Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures. Terminated |
OWB | K073290 K123529 |
| Dec 18, 2015 | GE 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 |
OWB | K022322 K042053 +4 |
| Oct 1, 2015 | Philips 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 |
OWB | K141979 |
| Aug 18, 2015 | Siemens 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 |
OWB | K123529 |
| Aug 17, 2015 | Siemens Medical Solutions USA, Inc CIOS ALPHA; image intensified fluoroscopic x-ray system Terminated |
OWB | K132094 |
| Aug 5, 2015 | Siemens 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 |
OWB | K123529 |
| Jul 20, 2015 | GE Healthcare GE Healthcare Precision RXi Digital system Terminated |
OWB | K082243 |
| Jul 20, 2015 | GE Healthcare GE Healthcare Precision RXi 23A/32A Analog System Terminated |
OWB | K082243 |
| Jul 3, 2015 | GE 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 |
OWB | K133278 |
| Jul 2, 2015 | Siemens 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 |
OWB | K132094 |
| Jun 25, 2015 | Siemens 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 |
OWB | K141574 |
| May 23, 2015 | Siemens 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 |
OWB | K062623 |
| Apr 14, 2015 | Siemens 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 |
OWB | K123529 |
| Apr 6, 2015 | Toshiba 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 |
OWB | K143225 |
| Feb 17, 2015 | Siemens 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 |
OWB | K133580 |
| Feb 3, 2015 | Philips 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 |
OWB | K033737 K041949 +2 |
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