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) |
|---|---|---|---|
| Jun 16, 2026 | PHILIPS 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 |
IZI | K023441 K050151 |
| Dec 16, 2021 | Shimadzu Medical Systems Digital Angiography System Bransist safire
Generator Model D150GC-40 Open, Classified |
IZI | K062360 |
| Nov 18, 2020 | Shimadzu 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 |
IZI | K943545 |
| Nov 18, 2020 | Shimadzu 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 |
IZI | K062360 |
| Dec 30, 2019 | Philips North America, LLC Poly G Integris H5000, System code 72246 Terminated |
IZI | K971365 |
| Dec 30, 2019 | Philips North America, LLC MultiDiagnost Eleva, System codes 722030
722016
722017
708032
708036
708034
708037
708038 Terminated |
IZI | K023441 K050151 |
| Apr 9, 2019 | Siemens 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 |
IZI | K123529 |
| Apr 9, 2019 | Siemens 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 |
IZI | K123529 |
| Apr 9, 2019 | Siemens 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 |
IZI | K073290 |
| Apr 9, 2019 | Siemens 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 |
IZI | K073290 |
| Mar 15, 2019 | GE 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 |
IZI | K181403 |
| Mar 15, 2019 | GE 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 |
IZI | K122457 |
| Mar 15, 2019 | GE 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 |
IZI | K111209 |
| Feb 28, 2019 | Philips 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 |
IZI | K023441 |
| Feb 19, 2019 | Philips 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 |
IZI | K031333 K033737 +3 |
| Feb 19, 2019 | Philips 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 |
IZI | K031333 K033737 +3 |
| Jan 14, 2019 | Shimadzu 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 |
IZI | K062360 |
| Oct 26, 2018 | Siemens 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 |
IZI | K073290 |
| Oct 19, 2018 | Siemens 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 |
IZI | K073290 |
| Sep 21, 2018 | Philips Electronics North America Corporation AIIuraXperFDlO/10, System Code 722011
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K041949 |
| Sep 21, 2018 | Philips Electronics North America Corporation AIIuraXperFDlO, System Code 722010
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K041949 |
| Sep 21, 2018 | Philips Electronics North America Corporation AlluraXperFOlO/lO, System Code 722005
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K041949 |
| Sep 21, 2018 | Philips 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 |
IZI | K041949 |
| Sep 21, 2018 | Philips 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 |
IZI | K041949 |
| Sep 21, 2018 | Philips 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 |
IZI | K041949 |
| Sep 21, 2018 | Philips 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 |
IZI | K033737 |
| Sep 21, 2018 | Philips 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 |
IZI | K033737 |
| Sep 21, 2018 | Philips 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 |
IZI | K033737 |
| Sep 21, 2018 | Philips 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 |
IZI | K033737 |
| Sep 21, 2018 | Philips 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 |
IZI | K031333 |
| Sep 21, 2018 | Philips 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 |
IZI | K031333 |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS SUITE, System Code 722199
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K031333 |
| Sep 21, 2018 | Philips 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 |
IZI | K031333 |
| Sep 21, 2018 | Philips 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 |
IZI | K031333 |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS CV, System Code 722030
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K031333 |
| Sep 21, 2018 | Philips 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 |
IZI | K031333 |
| Sep 21, 2018 | Philips 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 |
IZI | K031333 |
| May 3, 2018 | Philips 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 |
IZI | K023441 |
| Jan 12, 2018 | Shimadzu 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 |
IZI | K052500 |
| Jun 6, 2017 | Siemens Medical Solutions USA, Inc Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354 Terminated |
IZI | K073290 |
| Mar 30, 2017 | Siemens Medical Solutions USA, Inc Artis zee, Angiographic x-ray system Terminated |
IZI | K073290 |
| Feb 27, 2017 | Siemens Medical Solutions USA, Inc Artis Zee and Zeego fluoroscopic x-ray system Terminated |
IZI | K073290 |
| Feb 3, 2017 | Siemens 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 |
IZI | K073290 |
| Jan 20, 2017 | Philips 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 |
IZI | K041949 |
| Dec 9, 2016 | Philips Electronics North America Corporation Velara Generator with an old Firmware version used with the Philips Integris BH5000 Terminated |
IZI | K033737 K041949 |
| Dec 9, 2016 | Philips 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 |
IZI | K033737 K041949 |
| Nov 21, 2016 | GE Healthcare, LLC ADVANTX LCV+ Terminated |
IZI | K960575 |
| Nov 21, 2016 | GE Healthcare, LLC ADVANTX LCN+ Terminated |
IZI | K974367 |
| Nov 21, 2016 | GE Healthcare, LLC ADVANTX LCLP+ Terminated |
IZI | K974367 |
| Nov 21, 2016 | GE Healthcare, LLC ADVANTX LCA Terminated |
IZI | K945375 |
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