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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)
Jun 16, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva
Open, Classified
IZIK023441
K050151
Dec 16, 2021Shimadzu Medical Systems
Digital Angiography System Bransist safire Generator Model D150GC-40
Open, Classified
IZIK062360
Nov 18, 2020Shimadzu Medical Systems
MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational
Open, Classified
IZIK943545
Nov 18, 2020Shimadzu Medical Systems
Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and i
Open, Classified
IZIK062360
Dec 30, 2019Philips North America, LLC
Poly G Integris H5000, System code 72246
Terminated
IZIK971365
Dec 30, 2019Philips North America, LLC
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
Terminated
IZIK023441
K050151
Apr 9, 2019Siemens Medical Solutions USA, Inc
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and inter
Terminated
IZIK123529
Apr 9, 2019Siemens Medical Solutions USA, Inc
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and inter
Terminated
IZIK123529
Apr 9, 2019Siemens Medical Solutions USA, Inc
Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional proced
Terminated
IZIK073290
Apr 9, 2019Siemens Medical Solutions USA, Inc
Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and i
Terminated
IZIK073290
Mar 15, 2019GE Healthcare, LLC
Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and intervention
Open, Classified
IZIK181403
Mar 15, 2019GE Healthcare, LLC
Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventi
Open, Classified
IZIK122457
Mar 15, 2019GE Healthcare, LLC
Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and intervention
Open, Classified
IZIK111209
Feb 28, 2019Philips North America, LLC
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed al
Terminated
IZIK023441
Feb 19, 2019Philips Medical Systems Nederlands
Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD2
Terminated
IZIK031333
K033737 +3
Feb 19, 2019Philips Medical Systems Nederlands
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular,
Terminated
IZIK031333
K033737 +3
Jan 14, 2019Shimadzu Medical Systems Usa Com
BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of
Terminated
IZIK062360
Oct 26, 2018Siemens Medical Solutions USA, Inc
Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including,
Terminated
IZIK073290
Oct 19, 2018Siemens Medical Solutions USA, Inc
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interv
Terminated
IZIK073290
Sep 21, 2018Philips Electronics North America Corporation
AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK041949
Sep 21, 2018Philips Electronics North America Corporation
AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK041949
Sep 21, 2018Philips Electronics North America Corporation
AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK041949
Sep 21, 2018Philips Electronics North America Corporation
Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK041949
Sep 21, 2018Philips Electronics North America Corporation
AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK041949
Sep 21, 2018Philips Electronics North America Corporation
Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK041949
Sep 21, 2018Philips Electronics North America Corporation
Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK033737
Sep 21, 2018Philips Electronics North America Corporation
Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK033737
Sep 21, 2018Philips Electronics North America Corporation
Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK033737
Sep 21, 2018Philips Electronics North America Corporation
Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK033737
Sep 21, 2018Philips Electronics North America Corporation
NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK031333
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK031333
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK031333
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK031333
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK031333
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK031333
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK031333
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZIK031333
May 3, 2018Philips Medical Systems Nederlands
MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional
Terminated
IZIK023441
Jan 12, 2018Shimadzu Medical Systems
Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated an
Terminated
IZIK052500
Jun 6, 2017Siemens Medical Solutions USA, Inc
Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354
Terminated
IZIK073290
Mar 30, 2017Siemens Medical Solutions USA, Inc
Artis zee, Angiographic x-ray system
Terminated
IZIK073290
Feb 27, 2017Siemens Medical Solutions USA, Inc
Artis Zee and Zeego fluoroscopic x-ray system
Terminated
IZIK073290
Feb 3, 2017Siemens Medical Solutions USA, Inc
Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limite
Terminated
IZIK073290
Jan 20, 2017Philips Electronics North America Corporation
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pace
Terminated
IZIK041949
Dec 9, 2016Philips Electronics North America Corporation
Velara Generator with an old Firmware version used with the Philips Integris BH5000
Terminated
IZIK033737
K041949
Dec 9, 2016Philips Electronics North America Corporation
Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura
Terminated
IZIK033737
K041949
Nov 21, 2016GE Healthcare, LLC
ADVANTX LCV+
Terminated
IZIK960575
Nov 21, 2016GE Healthcare, LLC
ADVANTX LCN+
Terminated
IZIK974367
Nov 21, 2016GE Healthcare, LLC
ADVANTX LCLP+
Terminated
IZIK974367
Nov 21, 2016GE Healthcare, LLC
ADVANTX LCA
Terminated
IZIK945375

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