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Panels › Radiology › Product code IZI · Class 2

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)
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Top companies in IZI

DateFirm and productCodeLinked 510(k)
Aug 18, 2016NOVADAQ 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
IZIK042961
K060867 +4
Jul 19, 2016Philips Electronics North America Corporation
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
Terminated
IZIK023441
Jul 19, 2016Philips Electronics North America Corporation
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
Terminated
IZIK023441
Jul 13, 2016Siemens 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
IZIK123529
Jul 13, 2016Siemens 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
IZIK073290
Jul 13, 2016Siemens 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
IZIK010721
Jul 7, 2016Siemens 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
IZIK073290
K123529
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
IZIK073290
Mar 31, 2016Siemens 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
IZIK073290
Feb 19, 2016Siemens 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
IZIK073290
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
IZIK073290
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
IZIK073290
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
IZIK073290
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
IZIK073290
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
IZIK073290
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
IZIK073290
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
IZIK073290
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
IZIK073290
Feb 16, 2016Philips 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
IZIK033737
K041949 +1
Jan 30, 2016Philips 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
IZIK971365
Jan 30, 2016Philips 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
IZIK973482
Jan 30, 2016Philips 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
IZIK973482
Jan 30, 2016Philips 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
IZIK973482
Jan 30, 2016Philips 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
IZIK973482
Jan 30, 2016Philips 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
IZIK971365
Jan 30, 2016Philips 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
IZIK971365
Jan 30, 2016Philips 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
IZIK971365
Jan 30, 2016Philips 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
IZIK971365
Jan 30, 2016Philips 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
IZIK971365
Nov 13, 2015GE 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
IZIK122457
Nov 13, 2015GE 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
IZIK122457
Nov 10, 2015NeuroLogica Corporation
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Terminated
IZIK142492
K150097
Aug 5, 2015Siemens 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
IZIK010721
Aug 5, 2015Siemens 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
IZIK073290
Jul 3, 2015GE 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
IZIK122457
Jul 3, 2015GE 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
IZIK122457
Jul 3, 2015GE 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
IZIK122457
Jul 3, 2015GE 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
IZIK122457
Jul 3, 2015GE 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
IZIK122457
Jul 3, 2015GE 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
IZIK122457
Jul 3, 2015GE 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
IZIK122457
Jul 3, 2015GE 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
IZIK122457
Jul 3, 2015GE 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
IZIK122457
Jul 3, 2015GE 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
IZIK122457
Jul 3, 2015GE 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
IZIK122457
Jul 3, 2015GE 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
IZIK122457
Mar 2, 2015Philips Medical Systems, Inc.
Philips Medical System Allura Xper X-Ray Angiographic
Terminated
IZIK102005
Feb 26, 2015Philips Medical Systems, Inc.
Philips Multi Diagnost Eleva with FlatDetector
Terminated
IZIK050151
Feb 26, 2015Philips Medical Systems, Inc.
Philips Multi Diagnost Eleva II
Terminated
IZIK023441
Jan 14, 2015Siemens 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
IZIK073290

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