Home › Device types › IZI
System, X-Ray, Angiographic
FDA product code IZI · Class 2 · Radiology
376
Registered devices
7,784
Adverse events
259
Recalls
199
510(k) clearances
Devices with this code
Med-Syringe — ARGON MEDICAL DEVICES, INC.NA — B. BRAUN MEDICAL INC.Sterimed — STERIMED LLCOpen Field Fluorescence Imaging Head — Guangdong Optomedic Technologies, Inc.ARTIS icono floor — Siemens Healthcare GmbHDeRoyal — DEROYAL INDUSTRIES, INC.InfiMed i5, DSA, CCD Camera — INFIMED, INC.Sterimed — STERIMED LLCDeRoyal — DEROYAL INDUSTRIES, INC.DPM, Endoscopic Fluorescence Camera System — Zhuhai Dipu Medical Technology Co., Ltd.NOVADAQ®and PINPOINT® — Novadaq Technologies IncDISCOVERY — GE MEDICAL SYSTEMSSterimed — STERIMED LLCSterimed — STERIMED LLCSterimed — STERIMED LLCSterimed — STERIMED LLCSterimed — STERIMED LLCARTIS icono.explore floor — Siemens Healthcare GmbHMed-Syringe — ARGON MEDICAL DEVICES, INC.4KINSIGHT UHD Fluorescence Imaging System — Scivita Medical Technology Co., Ltd.Sterimed — STERIMED LLCArtis zee biplane — Siemens Healthcare GmbHIGS WF BP — GE MEDICAL SYSTEMSNAMIC — MEDLINE INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-18 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended ra |
| 2021-12-16 | Shimadzu Medical Systems | Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray rad |
| 2020-11-18 | Shimadzu Medical Systems | The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the d |
| 2020-11-18 | Shimadzu Medical Systems | The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the d |
| 2019-12-30 | Philips North America, LLC | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acq |
| 2019-12-30 | Philips North America, LLC | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acq |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
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