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Panels › Radiology › Product code OWB · Class 2

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)
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Top companies in OWB

DateFirm and productCodeLinked 510(k)
Feb 16, 2024PHILIPS 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
OWBK172822
K200917
Feb 16, 2024PHILIPS 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
OWBK031333
K130638 +4
Feb 16, 2024PHILIPS 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
OWBK130638
K130842 +4
Jan 30, 2024PHILIPS 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
OWBK200917
Jan 30, 2024PHILIPS 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
OWBK200917
Jan 26, 2024PHILIPS 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
OWBK200917
Dec 15, 2023PHILIPS 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
OWBK200917
Dec 15, 2023PHILIPS 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
OWBK161563
K162859 +1
Dec 9, 2023Siemens Medical Solutions USA, Inc
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Open, Classified
OWBK221516
Oct 27, 2023Siemens 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
OWBK203504
K210054
Oct 27, 2023Siemens Medical Solutions USA, Inc
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Open, Classified
OWBK210055
Sep 14, 2023PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Open, Classified
OWBK050151
K162859 +2
Sep 7, 2023Philips Medical Systems Nederland B.V.
Azurion
Open, Classified
OWBK172822
K181830 +1
Sep 7, 2023Philips Medical Systems Nederland B.V.
Allura Xper series
Open, Classified
OWBK162859
Aug 30, 2023PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Open, Classified
OWBK161563
K200917
Aug 24, 2023Medtronic 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
OWBK151000
Aug 11, 2023Canon Medical System, USA, INC.
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Open, Classified
OWBK210900
Aug 8, 2023Siemens Medical Solutions USA, Inc
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
Open, Classified
OWBK220409
Aug 8, 2023Siemens Medical Solutions USA, Inc
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
Open, Classified
OWBK220432
Aug 8, 2023Siemens Medical Solutions USA, Inc
ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
Open, Classified
OWBK220432
Aug 2, 2023PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20. X-ray Image guided Therapy System.
Open, Classified
OWBK200917
Aug 2, 2023PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 and FD20. X-ray Imaging System.
Open, Classified
OWBK130638
K162859
Jul 31, 2023GE OEC Medical Systems, Inc
OEC Elite Systems with 9-inch Image Intensifier
Open, Classified
OWBK170752
K171565 +2
Jul 31, 2023GE OEC Medical Systems, Inc
OEC 9800 Systems with 9-inch Image Intensifier
Open, Classified
OWBK021049
K111551 +1
Jul 27, 2023Siemens 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
OWBK210309
May 31, 2023NRT X-RAY A/S
Intelli-C, Left side suspended Tabletop, REF: 03400010
Open, Classified
OWBK173631
May 31, 2023NRT X-RAY A/S
Intelli-C, Right side suspended Tabletop, REF: 03400000
Open, Classified
OWBK173631
May 23, 2023Siemens Medical Solutions USA, Inc
LUMINOS Lotus Max (VF11)
Open, Classified
OWBK173639
May 23, 2023Siemens Medical Solutions USA, Inc
Luminos dRF Max (VE10, VF10, VF11)
Open, Classified
OWBK173639
May 23, 2023Siemens Medical Solutions USA, Inc
Luminos Agile Max (VE10, VF10, VF11)
Open, Classified
OWBK173639
May 2, 2023Siemens 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
OWBK163286
Apr 28, 2023Philips 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
OWBK173433
K212837
Apr 27, 2023Siemens 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
OWBK133580
Apr 20, 2023PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
Open, Classified
OWBK132147
Apr 20, 2023PHILIPS 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
OWBK181966
Mar 30, 2023Siemens 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
OWBK163286
Feb 23, 2023Siemens 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
OWBK173639
Feb 23, 2023Siemens 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
OWBK173639
Feb 23, 2023Siemens Medical Solutions USA, Inc
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
Open, Classified
OWBK062623
Feb 23, 2023Siemens 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
OWBK173639
Feb 23, 2023Siemens Medical Solutions USA, Inc
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
Open, Classified
OWBK062623
Feb 9, 2023Trackx 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
OWBK173736
K200360
Jan 30, 2023Siemens 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
OWBK181407
Jan 20, 2023Siemens Medical Solutions USA, Inc
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Open, Classified
OWBK173639
Jan 20, 2023Siemens Medical Solutions USA, Inc
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
Open, Classified
OWBK051602
K992660
Jan 13, 2023Siemens Medical Solutions USA, Inc
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Open, Classified
OWBK163286
K190768
Aug 26, 2022Siemens Medical Solutions USA, Inc
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Open, Classified
OWBK220432
Aug 26, 2022Siemens Medical Solutions USA, Inc
Artis pheno- Model No. 10849000
Open, Classified
OWBK220409
Jun 24, 2022Canon 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
OWBK181804
May 24, 2022Siemens Medical Solutions USA, Inc
Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
Terminated
OWBK181407

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