Interventional Fluoroscopic X-Ray System
FDA product code OWB · Class II (moderate risk) · 21 CFR 892.1650 · Radiology
Interventional fluoroscopy
325510(k) clearances
0PMA approvals
624recalls
Manufacturers
- Siemens Medical Solutions USA, Inc. 37
- Philips Medical Systems Nederland B.V. 29
- Ziehm Imaging GmbH 21
- Toshibamedical Systems Corporation 13
- Canon Medical Systems Corporation 12
- GE Medical Systems, LLC 11
- GE OEC Medical Systems, Inc 10
- Genoray Co., Ltd. 7
- Infimed, Inc. 6
- Volcano Corporation 5
- Controlrad, Inc. 5
- Omega Medical Imaging, Inc. 5
- GE Healthcare, LLC 5
- Philips Medical Systems North America, Inc. 5
- GE Medical Systems SCS 5
- Ge Dec Medical Systems 5
- Philips Medical Systems 5
- Canon, Inc. 4
- Toshiba America Medical Systems, In.C 3
- Saferay Spine, LLC 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253726 | uAngio AVIVA CXOWB · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/21/2026SE |
| K261413 | Extron 3;EXTRON 6OWB · Traditional | DRTECH Corporation | 08/19/2026SE |
| K254205 | Zenition 30OWB · Traditional | Philips Medical Systems Nederland B.V. | 08/07/2026SE |
| K260607 | Shield System (Siemens 30x40)OWB · Special | Radiaction , Ltd. | 07/31/2026SE |
| K253670 | SmartCT (R3.0 (L10))OWB · Abbreviated | Philips Medical Systems B.V. | 07/10/2026SE |
| K252735 | C-beamOWB · Traditional | Pulmera, Inc. | 05/22/2026SE |
| K252503 | Intelligent NROWB · Traditional | Canon, Inc. | 04/30/2026SE |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/24/2026SE |
| K253752 | ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/23/2026SE |
| K252229 | Belliger AceOWB · Traditional | Genoray Co., Ltd. | 04/02/2026SE |
| K252099 | TriniasOWB · Abbreviated | Shimadzu Corporation | 03/24/2026SE |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)OWB · Traditional | Canon Medical Systems Corporation | 03/10/2026SE |
| K252500 | CARA SystemOWB · Traditional | Cara Medical, Ltd. | 02/20/2026SE |
| K251992 | ArmSure Fluoroscopic Positioning SystemOWB · Traditional | Savfe Co. , Ltd. | 02/11/2026SE |
| K254186 | Azurion R3.1OWB · Special | Philips Medical Systems B.V. | 01/16/2026SE |
| K252068 | MC2 Portable X-ray SystemOWB · Traditional | Oxos Medical | 12/22/2025SE |
| K251893 | Skan C PulsarOWB · Traditional | Skanray Technologies Limited | 12/16/2025SE |
| K251199 | Allia MoveoOWB · Traditional | GE Medical Systems SCS | 12/09/2025SE |
| K250241 | Cios SelectOWB · Traditional | Siemens Medical Solutions USA, Inc. | 11/04/2025SE |
| K251827 | Azurion R3.1OWB · Traditional | Philips Medical Systems B.V. | 10/24/2025SE |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingOWB · Traditional | Canon Medical Systems Corporation | 10/10/2025SE |
| K251523 | Cios SpinOWB · Traditional | Siemens Medical Solutions USA, Inc. | 07/29/2025SE |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PADOWB · Traditional | Brainlab AG | 07/22/2025SE |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix ROWB · Traditional | Siemens Medical Solutions | 07/14/2025SE |
| K251520 | Cios Alpha; Cios FlowOWB · Traditional | Siemens Medical Solutions USA, Inc. | 07/09/2025SE |
| K243884 | TavipilotOWB · Traditional | Caranx Medical | 07/07/2025SE |
| K250010 | Extron 3; Extron 5; Extron 7OWB · Traditional | DRTECH Corporation | 06/10/2025SE |
| K243411 | Diagnostic X-ray SystemOWB · Traditional | Nanjing Perlove Medical Equipment Co., Ltd. | 05/19/2025SE |
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X)OWB · Traditional | Medicatech USA, Inc. | 05/16/2025SE |
| K250282 | Persona C HROWB · Traditional | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 04/30/2025SE |
| K243376 | uAngio AVIVA CXOWB · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/28/2025SE |
| K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version…OWB · Traditional | Medphoton GmbH | 03/28/2025SE |
| K243646 | Ziehm Solo FDOWB · Traditional | Ziehm Imaging GmbH | 03/17/2025SE |
| K243735 | Ziehm Vision FDOWB · Traditional | Ziehm Imaging GmbH | 03/13/2025SE |
| K243446 | 3DXROWB · Traditional | GE Medical Systems SCS | 02/25/2025SE |
| K243303 | Ziehm Vision RFD 3DOWB · Traditional | Ziehm Imaging GmbH | 01/21/2025SE |
| K243328 | Ziehm Vision RFDOWB · Traditional | Ziehm Imaging GmbH | 01/15/2025SE |
| K241567 | MC2 Portable X-ray SystemOWB · Traditional | Oxos Medical | 12/06/2024SE |
| K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…OWB · Traditional | Siemens Medical Solutions USA, Inc. | 10/22/2024SE |
| K233107 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5OWB · Traditional | Canon Medical Systems Corporation | 08/30/2024SE |
| K240465 | O-arm O2 Imaging SystemOWB · Traditional | Medtronic Navigation, Inc. | 06/21/2024SE |
| K233230 | See Factor CT3OWB · Traditional | Epica International, Inc. | 06/21/2024SE |
| K240224 | Zenition 90OWB · Abbreviated | Philips Medical Systems Nederlands B.V. | 05/22/2024SE |
| K240199 | IntraOp Alignment SystemOWB · Traditional | Alphatec Spine, Inc. | 05/22/2024SE |
| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless BlOWB · Traditional | Canon, Inc. | 04/26/2024SE |
| K233748 | CIARTIC Move (VB10)OWB · Traditional | Siemens Medical Solutions USA, Inc. | 03/15/2024SE |
| K232420 | Zenition 30OWB · Abbreviated | Philips Medical Systems Nederland B.V. | 02/16/2024SE |
| K240099 | Ziehm Vision RFDOWB · Special | Ziehm Imaging GmbH | 02/05/2024SE |
| K240020 | Ziehm Vision FDOWB · Special | Ziehm Imaging GmbH | 01/30/2024SE |
| K234109 | Ziehm Solo FDOWB · Special | Ziehm Imaging GmbH | 01/26/2024SE |
| K231700 | Ziehm Vision FDOWB · Special | Ziehm Imaging GmbH | 12/15/2023SE |
| K230949 | ARTIS pheno (VE30A)OWB · Traditional | Siemens Medical Solutions USA, Inc. | 12/15/2023SE |
| K230950 | ARTIS icono (VE30A)OWB · Traditional | Siemens Medical Solutions USA, Inc. | 12/14/2023SE |
| K231669 | Ziehm Solo FDOWB · Special | Ziehm Imaging GmbH | 12/12/2023SE |
| K231692 | Ziehm Vision RFDOWB · Special | Ziehm Imaging GmbH | 11/20/2023SE |
| K233200 | XPLUS 35 Series (XPLUS 35, XPLUS 35FD)OWB · Traditional | Gemss Healthcare Co., Ltd. | 11/16/2023SE |
| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OROWB · Special | GE Medical Systems SCS | 10/11/2023SE |
| K230871 | Extron 5; Extron 7OWB · Traditional | DRTECH Corporation | 08/17/2023SE |
| K230787 | Oscar 15 & Oscar 15iOWB · Traditional | Genoray Co., Ltd. | 07/20/2023SE |
| K231701 | Ziehm Vision RFD 3DOWB · Special | Ziehm Imaging GmbH | 07/10/2023SE |
| K222998 | F3OWB · Traditional | Acrew Imaging, Inc. | 06/20/2023SE |
| K230185 | ANT-X SystemOWB · Abbreviated | Ndr Medical Technology Pte. , Ltd. | 06/01/2023SE |
| K221344 | nView s1 with nav optionOWB · Traditional | Nview Medical | 12/28/2022SE |
| K223410 | Cios Select (VA21) Flat PanelOWB · Special | Siemens Medical Solutions USA, Inc. | 12/07/2022SE |
| K223409 | Cios Select (VA21) Image IntensifierOWB · Special | Siemens Medical Solutions USA, Inc. | 12/06/2022SE |
| K213768 | Bolt Navigation SystemOWB · Traditional | Circinus Medical Technology, LLC | 12/01/2022SE |
| K221281 | Multitom RaxOWB · Traditional | Siemens Medical Solutions | 11/17/2022SE |
| K222070 | EndoNautOWB · Traditional | Therenva Sas | 10/25/2022SE |
| K222080 | Garion Image-Intensified Fluoroscopic X-Ray System, MobileOWB · Traditional | Sg Healthcare Co, Ltd. | 10/06/2022SE |
| K222625 | Shield SystemOWB · Special | Radiaction , Ltd. | 09/30/2022SE |
| K220342 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3OWB · Traditional | Canon Medical Systems Corporation | 09/27/2022SE |
| K221922 | TriniasOWB · Special | Shimadzu Corporation Medical Systems Division | 07/28/2022SE |
| K221230 | TronOWB · Traditional | Xoran Technologies, LLC | 07/28/2022SE |
| K221516 | ARTIS icono (Ceiling Configuration)OWB · Traditional | Siemens Medical Solutions USA, Inc. | 07/19/2022SE |
| K220432 | ARTIS icono (VE21) SystemOWB · Traditional | Siemens Medical Solutions USA, Inc. | 06/29/2022SE |
| K220409 | ARTIS pheno (VE21) SystemOWB · Traditional | Siemens Medical Solutions USA, Inc. | 06/29/2022SE |
| K221335 | D²RS and D²RS 9090OWB · Special | Stephanix | 06/07/2022SE |
| K220311 | Cardiovascular Angiography SystemOWB · Traditional | Allengers Medical Systems Limited | 05/03/2022SE |
| K220946 | SURGIVISIO DeviceOWB · Special | Ecential Robotics | 04/15/2022SE |
| K212159 | Shield SystemOWB · Traditional | Radiaction , Ltd. | 03/30/2022SE |
| K220627 | SURGIVISIO DeviceOWB · Special | Ecential Robotics | 03/18/2022SE |
| K211780 | ZEN-2090 TurboOWB · Traditional | Genoray Co., Ltd. | 03/09/2022SE |
| K212212 | Multitom Rax with True2scale Body Scan OptionOWB · Traditional | Siemens Medical Solutions | 02/18/2022SE |
| K213479 | D²RS and D²RS 9090OWB · Traditional | Stephanix | 12/23/2021SE |
| K212442 | Cydar EV (Series B) and Cydar EV MapsOWB · Traditional | Cydar , Ltd. | 12/03/2021SE |
| K213455 | ControlRad Select Model ZOWB · Special | Controlrad, Inc. | 11/24/2021SE |
| K212336 | Soteria.AIOWB · Traditional | Omega Medical Imaging, LLC | 11/17/2021SE |
| K212956 | FDR Cross (DR-XD 3000)OWB · Traditional | Fujifilm Corporation | 11/08/2021SE |
| K212523 | VFSS Pro Mobile Digital Imaging SystemOWB · Traditional | Imagexray, LLC | 11/05/2021SE |
| K211064 | nView s1 with nav optionOWB · Traditional | Nview Medical | 10/29/2021SE |
| K212813 | Zenition 70OWB · Special | Philips Medical Systems Nederland B.V. | 10/01/2021SE |
| K212557 | Virtual C DRF-NEO Digital Imaging SystemOWB · Traditional | Portavision Medical, LLC | 09/24/2021SE |
| K212383 | EndoNautOWB · Special | Therenva Sas | 08/31/2021SE |
| K211777 | Arco Fp-SOWB · Traditional | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 08/13/2021SE |
| K210912 | Excelsius3DOWB · Traditional | Globus Medical, Inc. | 08/12/2021SE |
| K211782 | ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9OWB · Special | Controlrad, Inc. | 07/01/2021SE |
| K211191 | Virtual C DRF Digital Imaging SystemOWB · Traditional | Portavision Medical, LLC | 06/24/2021SE |
| K203535 | TriniasOWB · Traditional | Shimadzu Corporation Medical Systems | 04/28/2021SE |
| K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2OWB · Special | Canon Medical Systems Corporation | 04/12/2021SE |
| K203623 | StentBoost MobileOWB · Abbreviated | Philips India Limited | 04/05/2021SE |
| K202547 | Surgivisio systemOWB · Traditional | Surgivisio | 03/26/2021SE |
| K210309 | Cios Select (VA21) Flat PanelOWB · Special | Siemens Medical Solutions USA, Inc. | 03/05/2021SE |
| K210307 | Cios Select (VA21) Image IntensifierOWB · Special | Siemens Medical Solutions USA, Inc. | 03/04/2021SE |
| K201743 | ClarifEye R1.0, ClarifEye NeedleOWB · Abbreviated | Philips Medical Systems Nederlands B.V. | 02/23/2021SE |
| K201583 | SmartCT R1.0OWB · Abbreviated | Philips Medical Systems Nederland B.V. | 02/09/2021SE |
| K210055 | Cios AlphaOWB · Special | Siemens Medical Solutions USA, Inc. | 02/05/2021SE |
| K210054 | Cios SpinOWB · Special | Siemens Medical Systems USA, Inc. | 02/05/2021SE |
| K202431 | ControlRad Select Model ZOWB · Traditional | Controlrad, Inc. | 12/23/2020SE |
| K203504 | Cios FlowOWB · Special | Siemens Medical Solutions USA, Inc. | 12/22/2020SE |
| K203281 | Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XOWB · Traditional | Medphoton GmbH | 12/22/2020SE |
| K203551 | Alphenix, INFX-8000V/B, /S, V9.1OWB · Special | Canon Medical Systems Corporation | 12/18/2020SE |
| K202360 | Ziehm Vision RFD 3DOWB · Special | Ziehm Imaging GmbH | 09/16/2020SE |
| K200218 | Digiscan FDXOWB · Traditional | Allengers Medical Systems Limited | 07/13/2020SE |
| K201156 | ARTIS pheno (VE2)OWB · Traditional | Siemens Medical Solution USA, Inc. | 06/29/2020SE |
| K200663 | ControlRad Trace Model 9OWB · Traditional | Controlrad, Inc. | 06/24/2020SE |
| K201172 | CFP-3131, CFP-2222OWB · Traditional | Mx Imaging, Inc. | 05/29/2020SE |
| K200917 | Azurion R2.1OWB · Special | Philips Medical Systems Nederland B.V. | 05/01/2020SE |
| K200074 | O-arm O2 Imaging SystemOWB · Traditional | Medtronic, Inc. | 04/24/2020SE |
| K193326 | ARTIS IconoOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/16/2020SE |
| K200887 | AS-10OWB · Special | Canon, Inc. | 04/15/2020SE |
| K200022 | FLUSION-9001, Fluoroscopic C-arm Mobile X-ray SystemOWB · Traditional | Livermoretech, Inc. | 04/03/2020SE |
| K200360 | TrackXOWB · Special | Track X Technology, LLC | 03/05/2020SE |
| K192182 | C015OWB · Traditional | Micronica Srl | 01/17/2020SE |
| K193230 | Ziehm Vision FDOWB · Special | Ziehm Imaging GmbH | 12/20/2019SE |
| K183144 | uMC 560iOWB · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 12/19/2019SE |
| K190497 | Ziehm 8000OWB · Traditional | Ziehm Imaging GmbH | 11/20/2019SE |
| K190768 | ARTIS iconoOWB · Traditional | Siemens Medical Solutions USA, Inc. | 09/12/2019SE |
| K191503 | MobileRay Pulse SE Digital Imaging SystemOWB · Traditional | Portavision Medical, LLC | 09/04/2019SE |
| K182086 | Arco FPOWB · Traditional | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 08/20/2019SE |
| K190064 | nView system 1OWB · Traditional | Nview Medical, Inc. | 07/08/2019SE |
| K183109 | ControlRad Trace Model 8OWB · Traditional | Controlrad, Inc. | 05/13/2019SE |
| K190626 | SyncVision SystemOWB · Traditional | Volcano Corporation | 04/12/2019SE |
| K183101 | Zenition 50OWB · Abbreviated | Philips Medical Systems Nederland B.V. | 12/31/2018SE |
| K183040 | Zenition 70OWB · Abbreviated | Philips Medical Systems Nederland B.V. | 12/06/2018SE |
| K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OROWB · Traditional | GE Healthcare | 11/02/2018SE |
| K181550 | Cios SpinOWB · Traditional | Siemens Medical Solutions USA, Inc. | 10/30/2018SE |
| K181560 | Cios AlphaOWB · Traditional | Siemens Medical Systems USA, Inc. | 10/24/2018SE |
| K182546 | Alphenix, INFX-8000H/B, V8.0OWB · Traditional | Canon Medical Systems Corporation | 10/17/2018SE |
| K182415 | Alphenix, INFX-8000F/B, V8.0OWB · Traditional | Canon Medical Systems Corporation | 09/28/2018SE |
| K181415 | XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0OWB · Traditional | Canon Medical Systems Corporation | 09/10/2018SE |
| K181966 | SmartPerfusionOWB · Special | Philips Medical Systems Nederlands B.V. | 08/17/2018SE |
| K181943 | OSCAR (OSCAR Prime, OSCAR Classic)OWB · Traditional | Genoray Co., Ltd. | 08/17/2018SE |
| K181767 | Cios SelectOWB · Traditional | Siemens Medical Solutions USA, Inc. | 08/17/2018SE |
| K181407 | Artis zee/zeego & Artis Q/Q.zenOWB · Traditional | Siemens Medical Solution USA, Inc. | 08/15/2018SE |
| K181830 | Azurion R2.0OWB · Special | Philips Medical Systems Nederland B.V. | 08/02/2018SE |
| K181804 | Alphenix, INFX-8000C/B, V8.0OWB · Traditional | Canon Medical Systems Corporation | 08/02/2018SE |
| K181670 | Alphenix, INFX-8000V/B, V8.0OWB · Traditional | Canon Medical Systems Corporation | 07/25/2018SE |
| K181834 | Ultimax-i, DREX-UI80 (V1.60)OWB · Special | Canon Medical Systems Corporation | 07/19/2018SE |
| K173631 | Intelli-COWB · Traditional | Nrt X-Ray A/S | 07/11/2018SE |
| K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxOWB · Traditional | Siemens Medi Cal Solutions, Inc. | 04/02/2018SE |
| K180473 | ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR…OWB · Traditional | Ecotron Co., Ltd. | 03/23/2018SE |
| K173736 | TrackXOWB · Traditional | Track X Technology, LLC | 02/28/2018SE |
| K172180 | Oscar 15OWB · Traditional | Genoray Co., Ltd. | 02/09/2018SE |
| K171755 | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOWB · Special | Omega Medical Imaging, LLC | 02/09/2018SE |
| K173433 | ProxiDiagnost N90OWB · Traditional | Philips Medical Systems Dmc GmbH | 02/05/2018SE |
| K173664 | Medtronic O-arm O2 Imaging SystemOWB · Special | Medtronic, Inc. | 12/29/2017SE |
| K172863 | Infinix-i, INFX-8000V, V7.0OWB · Traditional | Toshibamedical Systems Corporation | 12/14/2017SE |
| K172822 | Azurion series R1.2OWB · Special | Philips Medical Systems Nederland B.V. | 11/22/2017SE |
| K173314 | LessRay SystemOWB · Traditional | Nu Vasive, Incorporated | 11/16/2017SE |
| K172700 | OEC OneOWB · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 11/09/2017SE |
| K172646 | XIDF-AWS801, Angio Workstation, V7.0OWB · Traditional | Toshibamedical Systems Corporation | 10/30/2017SE |
| K172307 | Dynamic Coronary Roadmap 2.0OWB · Abbreviated | Philips Medical Systems Nederland B.V. | 10/24/2017SE |
| K172574 | SyncVision SystemOWB · Traditional | Volcano Corporation | 10/05/2017SE |
| K171829 | EndoNautOWB · Traditional | Therenva Sas | 09/21/2017SE |
| K170800 | NuVasive LessRay with Enhanced TrackingOWB · Traditional | Nu Vasive, Incorporated | 08/18/2017SE |
| K171565 | OEC EliteOWB · Traditional | Ge Oec Medical Systems, Inc. | 08/10/2017SE |
| K170832 | Ultimax-i, DREX-UI80 V1.60OWB · Traditional | Toshibamedical Systems Corporation | 07/21/2017SE |
| K170909 | Infinix INFX-8000V, V6.40OWB · Traditional | Toshiba Medical Systems Coroporation | 06/16/2017SE |
| K170144 | StentBoost LiveOWB · Abbreviated | Philips Medical Stystems Nederland BV | 06/07/2017SE |
| K170130 | Dynamic Coronary RoadmapOWB · Abbreviated | Philips Medical Systems Nederland B.V. | 06/02/2017SE |
| K163140 | SPINEL 12HD Interventional Fluoroscopic Mobile X-ray SystemOWB · Traditional | Gemss Medical Systems Co., Ltd. | 05/26/2017SE |
| K171194 | AS-10, CXDI-401RFOWB · Traditional | Canon, Inc. | 05/24/2017SE |
| K170752 | OEC EliteOWB · Traditional | Oec Medical Systems, Inc. | 05/19/2017SE |
| K163286 | ARTIS phenoOWB · Traditional | Siemens Medical Solution USA, Inc. | 03/09/2017SE |
| K163715 | Allura Xper R9OWB · Special | Philips Medical Systems Nederland B.V. | 01/26/2017SE |
| K162859 | Allura Xper FD series and Allura Xper OR Table seriesOWB · Traditional | Philips Medical Systems Nederland B.V. | 12/02/2016SE |
| K162148 | Allura Xper R9OWB · Abbreviated | Philips Medical Systems Nethrlands BV | 11/23/2016SE |
| K162614 | Infinix, INFX-8000V, V6.35OWB · Special | Toshibamedical Systems Corporation | 10/17/2016SE |
| K160279 | ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemOWB · Traditional | Ecotron Co., Ltd. | 10/14/2016SE |
| K161976 | Ziehm Solo FDOWB · Traditional | Ziehm Imaging GmbH | 10/06/2016SE |
| K161756 | SyncVision SystemOWB · Traditional | Volcano Corporation | 09/05/2016SE |
| K160455 | AneurysmFlowOWB · Abbreviated | Philips Medical Systems Nederland B.V. | 08/25/2016SE |
| K160147 | CT TrueViewOWB · Abbreviated | Philips Medical Systems Nederland B.V. | 08/10/2016SE |
| K161839 | 2D Quantitative AnalysisOWB · Abbreviated | Philips Medical Systems Nederland B.V. | 07/29/2016SE |
| K161563 | Allura Xper FD series and Allura Xper OR Table seriesOWB · Traditional | Philips Medical Systems Nederland B.V. | 07/29/2016SE |
| K160088 | Cydar EVOWB · Traditional | Cydar , Ltd. | 07/07/2016SE |
| K153244 | Cios FusionOWB · Traditional | Siemens Medical Solutions USA, Inc. | 03/07/2016SE |
| K153232 | Cios SelectOWB · Special | Siemens Medical Solutions USA, Inc. | 02/10/2016SE |
| K152697 | INFX-8000C, V6.20OWB · Traditional | Toshibamedical Systems Corporation | 01/15/2016SE |
| K153147 | Cios ConnectOWB · Traditional | Siemens Medical Solutions USA, Inc. | 01/12/2016SE |
| K152696 | INFX-8000V, V6.20OWB · Traditional | Toshibamedical Systems Corporation | 01/12/2016SE |
| K152785 | XIDF-AWS801, Angio Workstation, V6.20OWB · Traditional | Toshibamedical Systems Corporation | 11/25/2015SE |
| K152928 | Multitom RaxOWB · Traditional | Siemens Medical Solutions USA, Inc. | 11/13/2015SE |
| K151598 | VesselNavigator Rel. 1.0OWB · Abbreviated | Philips Medical Systems Nederland B.V. | 08/17/2015SE |
| K151000 | O-Arm O2 Imaging SystemOWB · Traditional | Medtronic, Inc. | 08/06/2015SE |
| K151904 | SyncVision SystemOWB · Special | Volcano Corporation | 07/31/2015SE |
| K150967 | XIDF-AWS801, Angio Workstation, V6.10OWB · Traditional | Toshibamedical Systems Corporation | 06/18/2015SE |
| K142740 | Ziehm Vision RFD 3DOWB · Traditional | Ziehm Imaging GmbH | 04/06/2015SE |
| K142736 | XIDF-AWS801, Angio Workstation, v5.31OWB · Traditional | Toshibamedical Systems Corporation | 03/11/2015SE |
| K142273 | EmboGuideOWB · Traditional | Philips Medical Systems Nederland B.V. | 01/30/2015SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3014-2026 Class II | Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital…Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray… | Canon Medical System, USA, INC. | 08/04/2026Open, Classified |
| Z-2932-2026 Class II | Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235…Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality… | Philips Medical Systems Nederland B.V. | 07/16/2026Open, Classified |
| Z-2931-2026 Class II | Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079…Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that… | Philips Medical Systems Nederland B.V. | 07/16/2026Open, Classified |
| Z-2928-2026 Class II | Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039…Firmware issue potentially leading to loss of geometry movements. | Philips Medical Systems Nederland B.V. | 06/29/2026Open, Classified |
| Z-2893-2026 Class II | Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional…Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized… | Philips Medical Systems Nederland B.V. | 06/17/2026Open, Classified |
| Z-2892-2026 Class II | Philips Azurion under the following System Descriptions and corresponding model numbers:…Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized… | Philips Medical Systems Nederland B.V. | 06/17/2026Open, Classified |
| Z-2891-2026 Class II | Philips Allura under the following System Descriptions and corresponding model numbers:…Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized… | Philips Medical Systems Nederland B.V. | 06/17/2026Open, Classified |
| Z-2857-2026 Class II | Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog…Due to a defective circuit board that overheats | Oxos Medical Inc | 06/11/2026Open, Classified |
| Z-2648-2026 Class II | ARTIS icono ceiling. Model Number: 11328100.Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time… | Siemens Medical Solutions USA, Inc | 06/08/2026Open, Classified |
| Z-2643-2026 Class II | ARTIS icono floor. Model Number: 11327700.Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum… | Siemens Medical Solutions USA, Inc | 05/20/2026Open, Classified |
| Z-2642-2026 Class II | ARTIS icono ceiling. Model Number: 11328100.Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum… | Siemens Medical Solutions USA, Inc | 05/20/2026Open, Classified |
| Z-2641-2026 Class II | ARTIS icono biplane. Model Number: 11327600.Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum… | Siemens Medical Solutions USA, Inc | 05/20/2026Open, Classified |
| Z-2451-2026 Class II | Medtronic O-arm O2 Imaging System. Model Number: BI70002000.Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. | Medtronic Navigation, Inc.-Boxborough | 05/19/2026Open, Classified |
| Z-2412-2026 Class II | Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper…Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially… | Philips Medical Systems Nederland B.V. | 05/18/2026Open, Classified |
| Z-2259-2026 Class II | Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003…It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance… | Philips Medical Systems Nederland B.V. | 04/30/2026Open, Classified |
| Z-2258-2026 Class II | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221)…It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance… | Philips Medical Systems Nederland B.V. | 04/30/2026Open, Classified |
| Z-2229-2026 Class II | Integris-Allura system; System Code Description (Model Numbers): Integris CV…The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May… | Philips Medical Systems Nederland B.V. | 04/28/2026Open, Classified |
| Z-2228-2026 Class II | Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001)…The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May… | Philips Medical Systems Nederland B.V. | 04/28/2026Open, Classified |
| Z-2227-2026 Class II | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion…The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May… | Philips Medical Systems Nederland B.V. | 04/28/2026Open, Classified |
| Z-2225-2026 Class II | Philips Azurion systems not configured with an optional auxiliary pan handle. Includes…Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may… | Philips Medical Systems Nederland B.V. | 04/28/2026Open, Classified |
| Z-2318-2026 Class II | Allia Moveo angiographic X-ray systemGE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems… | GE Medical Systems, LLC | 04/20/2026Open, Classified |
| Z-2317-2026 Class II | Allia IGS Pulse angiographic X-ray systemGE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems… | GE Medical Systems, LLC | 04/20/2026Open, Classified |
| Z-2316-2026 Class II | Allia IGS 7 Pulse angiographic X-ray systemGE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems… | GE Medical Systems, LLC | 04/20/2026Open, Classified |
| Z-2315-2026 Class II | Allia IGS 5 Pulse angiographic X-ray systemGE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems… | GE Medical Systems, LLC | 04/20/2026Open, Classified |
| Z-2314-2026 Class II | Allia IGS 3 Pulse angiographic X-ray systemGE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems… | GE Medical Systems, LLC | 04/20/2026Open, Classified |
| Z-2294-2026 Class II | Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System…Electromagnetic contactors within high voltage generator may weld together, resulting in current being… | Shimadzu Medical Systems | 04/20/2026Open, Classified |
| Z-2170-2026 Class II | Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229)…Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor… | Philips Medical Systems Nederland B.V. | 03/31/2026Open, Classified |
| Z-1814-2026 Class II | ARTIS Pheno VE30A and VE40A, Model 10849000During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate… | Siemens Medical Solutions USA, Inc | 03/12/2026Open, Classified |
| Z-1653-2026 Class II | ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000…During patient examinations, the system may sporadically display a major increase of the x-ray dose applied… | Siemens Medical Solutions USA, Inc | 03/10/2026Open, Classified |
| Z-2206-2026 Class II | ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono…During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient.… | Siemens Medical Solutions USA, Inc | 03/09/2026Open, Classified |
| Z-2205-2026 Class II | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray systemDuring patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient.… | Siemens Medical Solutions USA, Inc | 03/09/2026Open, Classified |
| Z-1680-2026 Class II | Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1679-2026 Class II | Azurion 5 M12; System Code: (1)722227, (2)722231;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1678-2026 Class II | Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1677-2026 Class II | Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1676-2026 Class II | Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1675-2026 Class II | Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1674-2026 Class II | Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1673-2026 Class II | Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1672-2026 Class II | Allura Xper FD20/15 OR Table; System Code: 722059;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1671-2026 Class II | Allura Xper FD20/15; System Code: 722058;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1670-2026 Class II | Allura Xper FD20/20 OR Table; System Code: 722039;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1669-2026 Class II | Allura Xper FD20/20; System Code: 722038;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1668-2026 Class II | Allura Xper FD20/10; System Code: 722029;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1667-2026 Class II | ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1666-2026 Class II | ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1665-2026 Class II | ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1664-2026 Class II | ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1663-2026 Class II | ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |
| Z-1662-2026 Class II | ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | Philips Medical Systems Nederland B.V. | 03/03/2026Open, Classified |