System, X-Ray, Angiographic
Regulation 892.1600
2510(k)s in 12 months (199 all time)
1recalls in 12 months (259 all time)
240recalls that name a 510(k)
Top companies in IZI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2016 | NOVADAQ TECHNOLOGIES INC. Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001))
The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment Terminated |
IZI | K042961 K060867 +4 |
| Jul 19, 2016 | Philips Electronics North America Corporation MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036 Terminated |
IZI | K023441 |
| Jul 19, 2016 | Philips Electronics North America Corporation MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038. Terminated |
IZI | K023441 |
| Jul 13, 2016 | Siemens Medical Solutions USA, Inc ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22
AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed Terminated |
IZI | K123529 |
| Jul 13, 2016 | Siemens Medical Solutions USA, Inc ARTIS ZEE AND ZEEGO, system, x-ray, angiographic
AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and Terminated |
IZI | K073290 |
| Jul 13, 2016 | Siemens Medical Solutions USA, Inc AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic
AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane dia Terminated |
IZI | K010721 |
| Jul 7, 2016 | Siemens Medical Solutions USA, Inc Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled
Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255
Artis zee / Terminated |
IZI | K073290 K123529 |
| 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 |
IZI | K073290 |
| Mar 31, 2016 | Siemens Medical Solutions USA, Inc system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959
Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging Terminated |
IZI | K073290 |
| Feb 19, 2016 | Siemens Medical Solutions USA, Inc Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operati Terminated |
IZI | K073290 |
| 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 |
IZI | K073290 |
| 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 |
IZI | K073290 |
| 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 |
IZI | K073290 |
| 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 |
IZI | K073290 |
| 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 |
IZI | K073290 |
| 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 |
IZI | K073290 |
| 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 |
IZI | K073290 |
| 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 |
IZI | K073290 |
| Feb 16, 2016 | Philips Electronics North America Corporation Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C Terminated |
IZI | K033737 K041949 +1 |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS BV3000 MONO; Model Number: 72241
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Bi Terminated |
IZI | K971365 |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS BV5000: Model Number: 72249
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | K973482 |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS V5000: Model Number: 72248
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | K973482 |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS BH5000; Model Number: 72247
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | K973482 |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS H5000; Model Number: 72246
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | K973482 |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS V3000; Model Number: 72243, 72244, 72245
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS All Terminated |
IZI | K971365 |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS BH3000; Model Number: 72242
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | K971365 |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS BN/BV3000; Model Number: 72240
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Bipl Terminated |
IZI | K971365 |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS HM3000; Model Number: 72239
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | K971365 |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS H3000; Model Number: 72238
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | K971365 |
| Nov 13, 2015 | GE Medical Systems, LLC GE Healthcare Optima IGS 320.
Product Usage:
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anat Terminated |
IZI | K122457 |
| Nov 13, 2015 | GE Medical Systems, LLC GE Healthcare Optima CL323i
Product Usage:
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anato Terminated |
IZI | K122457 |
| Nov 10, 2015 | NeuroLogica Corporation Samsung GM60A-40S
Intended for use in generating radiographic images of human anatomy. Terminated |
IZI | K142492 K150097 |
| Aug 5, 2015 | Siemens Medical Solutions USA, Inc Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Proce Terminated |
IZI | K010721 |
| Aug 5, 2015 | Siemens Medical Solutions USA, Inc Siemens Artis zee systems;
dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Terminated |
IZI | K073290 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Optima CL 323i.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova IGS 630.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova IGS 620.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova IGS 540.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova IGS 530.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova IGS 520.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova 3131IQ.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova 3100IQ.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova 2121IQ.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova 2100IQ.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Discovery IGS 730.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Jul 3, 2015 | GE Healthcare GE Healthcare Optima IGS 320.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | K122457 |
| Mar 2, 2015 | Philips Medical Systems, Inc. Philips Medical System Allura Xper X-Ray Angiographic Terminated |
IZI | K102005 |
| Feb 26, 2015 | Philips Medical Systems, Inc. Philips Multi Diagnost Eleva with FlatDetector Terminated |
IZI | K050151 |
| Feb 26, 2015 | Philips Medical Systems, Inc. Philips Multi Diagnost Eleva II Terminated |
IZI | K023441 |
| Jan 14, 2015 | Siemens Medical Solutions USA, Inc Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedu Terminated |
IZI | K073290 |
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