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) |
|---|---|---|---|
| May 3, 2022 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion systems with software release R1.x Open, Classified |
OWB | K172822 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q.zen biplane, Model Number 10848355 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q.zen ceiling, Model Number 10848354 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q.zen floor, Model Number 10848353 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q zeego, Model Number 10848283 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q biplane, Model Number 10848282 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q ceiling, Model Number 10848281 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis Q floor, Model Number 10848280 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zeego, Model Number 10280959 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee biplane MN, Model Number 10094143 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee floor MN, Model Number 10094142 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee biplane, Model Number 10094141 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee multi-purpose, Model Number 10094139 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee ceiling, Model Number 10094137 Open, Classified |
OWB | K181407 |
| Apr 21, 2022 | Siemens Medical Solutions USA, Inc Artis zee floor, Model Number 10094135 Open, Classified |
OWB | K181407 |
| Apr 11, 2022 | Siemens Medical Solutions USA, Inc Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures
SMN: 11327700 Open, Classified |
OWB | K190768 K193326 |
| Apr 11, 2022 | Siemens Medical Solutions USA, Inc Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures
SMN: 11327600 Open, Classified |
OWB | K190768 K193326 |
| Feb 25, 2022 | Siemens 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 |
OWB | K163286 K190768 +2 |
| Feb 25, 2022 | Siemens 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 |
OWB | K201156 |
| Feb 25, 2022 | Siemens 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 |
OWB | K193326 |
| Feb 25, 2022 | Siemens 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 |
OWB | K193326 |
| Feb 2, 2022 | Philips Healthcare Philips StentBoost Live R2.0 application, when used with the
Philips Azurion with software release R2.x Terminated |
OWB | K200917 |
| Jan 31, 2022 | Canon Medical System, USA, INC. INFX-8000V. For radiographic and fluoroscopic studies and intervention. Open, Classified |
OWB | K170909 |
| Jan 21, 2022 | NRT 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 |
OWB | K173631 |
| Jan 19, 2022 | Volcano Corporation SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x Open, Classified |
OWB | K132558 K151904 +3 |
| Jan 10, 2022 | Philips 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 |
OWB | K161563 K200917 |
| Dec 20, 2021 | Canon 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 |
OWB | K181670 K181804 +2 |
| Dec 16, 2021 | Shimadzu Medical Systems Digital Angiography System Shimadzu Trinias
Generator Model: D150GC-40 Open, Classified |
OWB | K123508 |
| Dec 2, 2021 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veradius Unity, Model #718132 Open, Classified |
OWB | K142708 |
| Dec 2, 2021 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Zenition 70, Model #718133 Open, Classified |
OWB | K183040 |
| Dec 2, 2021 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Zenition 50, Model #718096 Open, Classified |
OWB | K183101 |
| Nov 24, 2021 | Philips 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 |
OWB | K141979 K161563 |
| Nov 24, 2021 | Philips 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 |
OWB | K141979 K161563 |
| Nov 19, 2021 | Philips 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 |
OWB | K130842 K141979 +1 |
| Nov 12, 2021 | Philips 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 |
OWB | K181830 |
| Nov 12, 2021 | Philips North America Llc Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. .
Model Number: 718132 Open, Classified |
OWB | K142708 |
| Nov 12, 2021 | Philips 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 |
OWB | K010435 |
| Nov 12, 2021 | Philips 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 |
OWB | K010435 |
| Oct 20, 2021 | Siemens 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 |
OWB | K181407 |
| Oct 20, 2021 | Siemens 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 |
OWB | K181407 |
| Oct 20, 2021 | Siemens 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 |
OWB | K181407 |
| Oct 20, 2021 | Siemens 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 |
OWB | K181407 |
| Oct 20, 2021 | Siemens 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 |
OWB | K181407 |
| Oct 20, 2021 | Siemens 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 |
OWB | K181407 |
| Oct 20, 2021 | Siemens 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 |
OWB | K181407 |
| Oct 20, 2021 | Siemens 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 |
OWB | K181407 |
| Oct 20, 2021 | Siemens 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 |
OWB | K181407 |
| Oct 20, 2021 | Siemens 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 |
OWB | K181407 |
| Oct 12, 2021 | Siemens Medical Solutions USA, Inc Artis icono floor with software VE20C-diagnostic imaging angiography system
Model: 11327700 Terminated |
OWB | K193326 |
| Oct 12, 2021 | Siemens Medical Solutions USA, Inc Artis icono biplane with software VE20C-diagnostic imaging angiography system
Model: 11327600 Terminated |
OWB | K193326 |
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