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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 10, 2020Philips North America, LLC
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion
Terminated
OWBK162148
K172822 +1
Jan 24, 2020Siemens Medical Solutions USA, Inc
ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging
Terminated
OWBK163286
Jan 8, 2020Siemens Medical Solutions USA, Inc
Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has med
Terminated
OWBK173639
Jan 8, 2020Siemens Medical Solutions USA, Inc
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical
Terminated
OWBK173639
Jan 8, 2020Siemens Medical Solutions USA, Inc
Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is desig
Terminated
OWBK173639
Jan 8, 2020Siemens Medical Solutions USA, Inc
Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has med
Terminated
OWBK173639
Jan 8, 2020Siemens Medical Solutions USA, Inc
Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical
Terminated
OWBK173639
Jan 7, 2020Siemens Medical Solutions USA, Inc
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
Terminated
OWBK132094
Dec 31, 2019Medtronic Navigation, Inc.-Littleton
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Terminated
OWBK151000
K173664
Dec 30, 2019Philips North America, LLC
Cardio Vascular-Allura Centron, system code 722400
Terminated
OWBK141979
Dec 30, 2019Philips North America, LLC
Allura CV20, system code 722031
Terminated
OWBK141979
Dec 30, 2019Philips North America, LLC
OmniDiagnost Eleva System codes 708028 708027
Terminated
OWBK032046
Dec 30, 2019Philips North America, LLC
Integris Allura 9, system codes 722018 722021
Terminated
OWBK002016
Dec 30, 2019Philips North America, LLC
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
Terminated
OWBK002016
Dec 30, 2019Philips North America, LLC
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is
Terminated
OWBK141979
Dec 20, 2019Siemens Medical Solutions USA, Inc
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including,
Terminated
OWBK163286
Nov 20, 2019Philips North America, LLC
ProxiDiagnost N90
Terminated
OWBK173433
Nov 14, 2019Siemens Medical Solutions USA, Inc
Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
Terminated
OWBK181407
Nov 4, 2019Shimadzu Medical Systems
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology,
Completed
OWBK123508
Jul 30, 2019Siemens Medical Solutions USA, Inc
Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor
Terminated
OWBK181407
Jul 16, 2019Philips North America, LLC
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Mod
Terminated
OWBK172822
Jun 20, 2019Siemens Medical Solutions USA, Inc
Cios care fusion system
Terminated
OWBK153244
Jun 20, 2019Siemens Medical Solutions USA, Inc
Cios Alpha VA20/ VA30 mobile X-Ray systems
Terminated
OWBK132094
K181560
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zeego, Model Number 10280959
Terminated
OWBK181407
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee biplane MN, Model Number 10094143
Terminated
OWBK181407
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee floor MN, Model Number 10094142
Terminated
OWBK181407
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee biplane, Model Number 10094141
Terminated
OWBK181407
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee multi, Model Number 10094139
Terminated
OWBK181407
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee ceiling, Model Number 10094137
Terminated
OWBK181407
Jun 12, 2019Siemens Medical Solutions USA, Inc
Artis zee floor, Model Number 10094135
Terminated
OWBK181407
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis dBC, Model Number 7728392
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis TC, Model Number 7728350
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis dFC, Model Number 7727717
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis dFA, Model Number 7555373
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis dMP, Model Number 7555365
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis dBA, Model Number 7555357
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis dTC, Model Number 7413078
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis dFC, Model Number 7412807
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis dTA, Model Number 7008605
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis TA, Model Number 7007755
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis dBC, Model Number 5917054
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis BA, Model Number 5904656
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis BC, Model Number 5904649
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis MP, Model Number 5904466
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis FA, Model Number 5904441
Terminated
OWBK052202
Jun 12, 2019Siemens Medical Solutions USA, Inc
AXIOM Artis FC, Model Number 5904433
Terminated
OWBK052202
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
Terminated
OWBK163286
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
Terminated
OWBK181407
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
Terminated
OWBK181407
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
Terminated
OWBK181407

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