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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)
May 3, 2022PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion systems with software release R1.x
Open, Classified
OWBK172822
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q.zen biplane, Model Number 10848355
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q.zen ceiling, Model Number 10848354
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q.zen floor, Model Number 10848353
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q zeego, Model Number 10848283
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q biplane, Model Number 10848282
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q ceiling, Model Number 10848281
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis Q floor, Model Number 10848280
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zeego, Model Number 10280959
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee biplane MN, Model Number 10094143
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee floor MN, Model Number 10094142
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee biplane, Model Number 10094141
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee multi-purpose, Model Number 10094139
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee ceiling, Model Number 10094137
Open, Classified
OWBK181407
Apr 21, 2022Siemens Medical Solutions USA, Inc
Artis zee floor, Model Number 10094135
Open, Classified
OWBK181407
Apr 11, 2022Siemens Medical Solutions USA, Inc
Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
Open, Classified
OWBK190768
K193326
Apr 11, 2022Siemens Medical Solutions USA, Inc
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Open, Classified
OWBK190768
K193326
Feb 25, 2022Siemens Medical Solutions USA, Inc
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number:
Open, Classified
OWBK163286
K190768 +2
Feb 25, 2022Siemens Medical Solutions USA, Inc
Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Open, Classified
OWBK201156
Feb 25, 2022Siemens Medical Solutions USA, Inc
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
Open, Classified
OWBK193326
Feb 25, 2022Siemens Medical Solutions USA, Inc
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
Open, Classified
OWBK193326
Feb 2, 2022Philips Healthcare
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Terminated
OWBK200917
Jan 31, 2022Canon Medical System, USA, INC.
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Open, Classified
OWBK170909
Jan 21, 2022NRT X-RAY A/S
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
Open, Classified
OWBK173631
Jan 19, 2022Volcano Corporation
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Open, Classified
OWBK132558
K151904 +3
Jan 10, 2022Philips North America Llc
Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722
Open, Classified
OWBK161563
K200917
Dec 20, 2021Canon Medical System, USA, INC.
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Open, Classified
OWBK181670
K181804 +2
Dec 16, 2021Shimadzu Medical Systems
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
Open, Classified
OWBK123508
Dec 2, 2021PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veradius Unity, Model #718132
Open, Classified
OWBK142708
Dec 2, 2021PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Zenition 70, Model #718133
Open, Classified
OWBK183040
Dec 2, 2021PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Zenition 50, Model #718096
Open, Classified
OWBK183101
Nov 24, 2021Philips North America Llc
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
Open, Classified
OWBK141979
K161563
Nov 24, 2021Philips North America Llc
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008,
Open, Classified
OWBK141979
K161563
Nov 19, 2021Philips North America Llc
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally inva
Terminated
OWBK130842
K141979 +1
Nov 12, 2021Philips North America Llc
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 7220
Terminated
OWBK181830
Nov 12, 2021Philips North America Llc
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
Open, Classified
OWBK142708
Nov 12, 2021Philips North America Llc
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
Open, Classified
OWBK010435
Nov 12, 2021Philips North America Llc
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Open, Classified
OWBK010435
Oct 20, 2021Siemens Medical Solutions USA, Inc
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355
Terminated
OWBK181407
Oct 20, 2021Siemens Medical Solutions USA, Inc
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
Terminated
OWBK181407
Oct 20, 2021Siemens Medical Solutions USA, Inc
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
Terminated
OWBK181407
Oct 20, 2021Siemens Medical Solutions USA, Inc
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282
Terminated
OWBK181407
Oct 20, 2021Siemens Medical Solutions USA, Inc
Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
Terminated
OWBK181407
Oct 20, 2021Siemens Medical Solutions USA, Inc
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280
Terminated
OWBK181407
Oct 20, 2021Siemens Medical Solutions USA, Inc
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
Terminated
OWBK181407
Oct 20, 2021Siemens Medical Solutions USA, Inc
Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139
Terminated
OWBK181407
Oct 20, 2021Siemens Medical Solutions USA, Inc
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
Terminated
OWBK181407
Oct 20, 2021Siemens Medical Solutions USA, Inc
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
Terminated
OWBK181407
Oct 12, 2021Siemens Medical Solutions USA, Inc
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Terminated
OWBK193326
Oct 12, 2021Siemens Medical Solutions USA, Inc
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Terminated
OWBK193326

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