Interventional Fluoroscopic X-Ray System
Regulation 892.1650
18510(k)s in 12 months (325 all time)
110recalls in 12 months (638 all time)
607recalls that name a 510(k)
Top companies in OWB
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system.
Affected PCs: XRay PC, Suite PC, and FlexViewing PC
Azurion Model Nam Open, Classified |
OWB | K172822 K200917 |
| Feb 16, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems.
Affected PCs: Imaging Processing PC, Host PC, FlexVision PC
Allura X Open, Classified |
OWB | K031333 K130638 +4 |
| Feb 16, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems.
Allura Xper Model Name - Model Number:
Allura Xper FD1 Open, Classified |
OWB | K130638 K130842 +4 |
| Jan 30, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) Open, Classified |
OWB | K200917 |
| Jan 30, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) Open, Classified |
OWB | K200917 |
| Jan 26, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion system, Interventional fluoroscopic x-ray system.
System Product Name - Model Numbers
Azurion 3M12 -722063, 722221;
Azurion 3M15 - 722064, 722222;
Azurion 5M12 - 722227;
Azurion 5M2 Open, Classified |
OWB | K200917 |
| Dec 15, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion systems with monoplane fixed ceiling mounts:
722078 Azurion 7 M12
722079 Azurion 7 M20
722223 Azurion 7 M12
722224 Azurion 7 M20
722227 Azurion 5 M12
722228 Azurion 5 M20 Open, Classified |
OWB | K200917 |
| Dec 15, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura systems with monoplane fixed ceiling mounts:
722001 Allura Xper FD10C
722003 Allura Xper FD10
722006 Allura Xper FD20
722010 Allura Xper FD10
722012 Allura Xper FD20
722015 Allura Xper Open, Classified |
OWB | K161563 K162859 +1 |
| Dec 9, 2023 | Siemens Medical Solutions USA, Inc ARTIS icono (ceiling configuration), Fluoroscopic x-ray system;
Model no. 11328100 Open, Classified |
OWB | K221516 |
| Oct 27, 2023 | Siemens Medical Solutions USA, Inc ***Updated 12/4/23***
(1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes.
Material Number: 11108110 Open, Classified |
OWB | K203504 K210054 |
| Oct 27, 2023 | Siemens Medical Solutions USA, Inc Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment.
11105200 Open, Classified |
OWB | K210055 |
| Sep 14, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems Open, Classified |
OWB | K050151 K162859 +2 |
| Sep 7, 2023 | Philips Medical Systems Nederland B.V. Azurion Open, Classified |
OWB | K172822 K181830 +1 |
| Sep 7, 2023 | Philips Medical Systems Nederland B.V. Allura Xper series Open, Classified |
OWB | K162859 |
| Aug 30, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems Open, Classified |
OWB | K161563 K200917 |
| Aug 24, 2023 | Medtronic Navigation, Inc.-Littleton The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater Open, Classified |
OWB | K151000 |
| Aug 11, 2023 | Canon Medical System, USA, INC. INFX-8000C XGCP-930AA TABLE SIDE CONSOLE,
INFX-8000C XGCP-930BA TABLE SIDE CONSOLE Open, Classified |
OWB | K210900 |
| Aug 8, 2023 | Siemens Medical Solutions USA, Inc ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Material Number: 10849000 Open, Classified |
OWB | K220409 |
| Aug 8, 2023 | Siemens Medical Solutions USA, Inc ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Material Number: 11327700 Open, Classified |
OWB | K220432 |
| Aug 8, 2023 | Siemens Medical Solutions USA, Inc ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Material Number: 11327600 Open, Classified |
OWB | K220432 |
| Aug 2, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20. X-ray Image guided Therapy System. Open, Classified |
OWB | K200917 |
| Aug 2, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10 and FD20. X-ray Imaging System. Open, Classified |
OWB | K130638 K162859 |
| Jul 31, 2023 | GE OEC Medical Systems, Inc OEC Elite Systems with 9-inch Image Intensifier Open, Classified |
OWB | K170752 K171565 +2 |
| Jul 31, 2023 | GE OEC Medical Systems, Inc OEC 9800 Systems with 9-inch Image Intensifier Open, Classified |
OWB | K021049 K111551 +1 |
| Jul 27, 2023 | Siemens Medical Solutions USA, Inc Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.
M Open, Classified |
OWB | K210309 |
| May 31, 2023 | NRT X-RAY A/S Intelli-C, Left side suspended Tabletop, REF: 03400010 Open, Classified |
OWB | K173631 |
| May 31, 2023 | NRT X-RAY A/S Intelli-C, Right side suspended Tabletop, REF: 03400000 Open, Classified |
OWB | K173631 |
| May 23, 2023 | Siemens Medical Solutions USA, Inc LUMINOS Lotus Max (VF11) Open, Classified |
OWB | K173639 |
| May 23, 2023 | Siemens Medical Solutions USA, Inc Luminos dRF Max (VE10, VF10, VF11) Open, Classified |
OWB | K173639 |
| May 23, 2023 | Siemens Medical Solutions USA, Inc Luminos Agile Max (VE10, VF10, VF11) Open, Classified |
OWB | K173639 |
| May 2, 2023 | Siemens Medical Solutions USA, Inc ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)-
Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Model: 108490 Open, Classified |
OWB | K163286 |
| Apr 28, 2023 | Philips North America Llc Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system Open, Classified |
OWB | K173433 K212837 |
| Apr 27, 2023 | Siemens Medical Solutions USA, Inc ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures.
Material Number: 10848600 Open, Classified |
OWB | K133580 |
| Apr 20, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 Open, Classified |
OWB | K132147 |
| Apr 20, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 Open, Classified |
OWB | K181966 |
| Mar 30, 2023 | Siemens Medical Solutions USA, Inc ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system.
Material # 10849000. Open, Classified |
OWB | K163286 |
| Feb 23, 2023 | Siemens Medical Solutions USA, Inc Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for
radiographic and fluoroscopic studie
Model Number:10762473 Open, Classified |
OWB | K173639 |
| Feb 23, 2023 | Siemens Medical Solutions USA, Inc Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for
radiographic and fluoroscopic studie
Model Number:10762471 Open, Classified |
OWB | K173639 |
| Feb 23, 2023 | Siemens Medical Solutions USA, Inc Luminos dRF with software VD10- A diagnostic imaging system for
radiographic and fluoroscopic studies
Model Number: 10094200 Open, Classified |
OWB | K062623 |
| Feb 23, 2023 | Siemens Medical Solutions USA, Inc Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for
radiographic and fluoroscopic studies
Model Number: 10762472 Open, Classified |
OWB | K173639 |
| Feb 23, 2023 | Siemens Medical Solutions USA, Inc Luminos Agile with software VC10 - A diagnostic imaging system for
radiographic and fluoroscopic studies.
Model Number: 10502200 Open, Classified |
OWB | K062623 |
| Feb 9, 2023 | Trackx Technology Inc TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile. Terminated |
OWB | K173736 K200360 |
| Jan 30, 2023 | Siemens Medical Solutions USA, Inc System Material #
Artis zee floor 10094135
Artis zee ceiling 10094137
Artis zee multi-purpose 10094139
Artis zee biplane 10094141
Artis zeego 10280959
Artis Q floor 10848280
Artis Q ceiling 10848281 Open, Classified |
OWB | K181407 |
| Jan 20, 2023 | Siemens Medical Solutions USA, Inc Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max Open, Classified |
OWB | K173639 |
| Jan 20, 2023 | Siemens Medical Solutions USA, Inc AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF Open, Classified |
OWB | K051602 K992660 |
| Jan 13, 2023 | Siemens Medical Solutions USA, Inc ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor Open, Classified |
OWB | K163286 K190768 |
| Aug 26, 2022 | Siemens Medical Solutions USA, Inc Artis icono biplane- Model No. 11327600
Artis icono floor- Model No. 11327700 Open, Classified |
OWB | K220432 |
| Aug 26, 2022 | Siemens Medical Solutions USA, Inc Artis pheno- Model No. 10849000 Open, Classified |
OWB | K220409 |
| Jun 24, 2022 | Canon Medical System, USA, INC. System: Alphenix 4D CT in combination with CAS-930A (C arm Support)
Model Number:
INFX-8000C/BF,
INFX-8000C/BH,
INFX-8000C/SW Open, Classified |
OWB | K181804 |
| May 24, 2022 | Siemens Medical Solutions USA, Inc Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System Terminated |
OWB | K181407 |
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