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 10, 2020 | Philips 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 |
OWB | K162148 K172822 +1 |
| Jan 24, 2020 | Siemens 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 |
OWB | K163286 |
| Jan 8, 2020 | Siemens 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 |
OWB | K173639 |
| Jan 8, 2020 | Siemens 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 |
OWB | K173639 |
| Jan 8, 2020 | Siemens 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 |
OWB | K173639 |
| Jan 8, 2020 | Siemens 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 |
OWB | K173639 |
| Jan 8, 2020 | Siemens 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 |
OWB | K173639 |
| Jan 7, 2020 | Siemens 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 |
OWB | K132094 |
| Dec 31, 2019 | Medtronic Navigation, Inc.-Littleton O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 Terminated |
OWB | K151000 K173664 |
| Dec 30, 2019 | Philips North America, LLC Cardio Vascular-Allura Centron, system code 722400 Terminated |
OWB | K141979 |
| Dec 30, 2019 | Philips North America, LLC Allura CV20, system code 722031 Terminated |
OWB | K141979 |
| Dec 30, 2019 | Philips North America, LLC OmniDiagnost Eleva System codes 708028
708027 Terminated |
OWB | K032046 |
| Dec 30, 2019 | Philips North America, LLC Integris Allura 9, system codes 722018
722021 Terminated |
OWB | K002016 |
| Dec 30, 2019 | Philips North America, LLC Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044) Terminated |
OWB | K002016 |
| Dec 30, 2019 | Philips 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 |
OWB | K141979 |
| Dec 20, 2019 | Siemens 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 |
OWB | K163286 |
| Nov 20, 2019 | Philips North America, LLC ProxiDiagnost N90 Terminated |
OWB | K173433 |
| Nov 14, 2019 | Siemens Medical Solutions USA, Inc Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C Terminated |
OWB | K181407 |
| Nov 4, 2019 | Shimadzu 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 |
OWB | K123508 |
| Jul 30, 2019 | Siemens 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 |
OWB | K181407 |
| Jul 16, 2019 | Philips 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 |
OWB | K172822 |
| Jun 20, 2019 | Siemens Medical Solutions USA, Inc Cios care fusion system Terminated |
OWB | K153244 |
| Jun 20, 2019 | Siemens Medical Solutions USA, Inc Cios Alpha VA20/ VA30 mobile X-Ray systems Terminated |
OWB | K132094 K181560 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zeego, Model Number 10280959 Terminated |
OWB | K181407 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee biplane MN, Model Number 10094143 Terminated |
OWB | K181407 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee floor MN, Model Number 10094142 Terminated |
OWB | K181407 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee biplane, Model Number 10094141 Terminated |
OWB | K181407 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee multi, Model Number 10094139 Terminated |
OWB | K181407 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee ceiling, Model Number 10094137 Terminated |
OWB | K181407 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc Artis zee floor, Model Number 10094135 Terminated |
OWB | K181407 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dBC, Model Number 7728392 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis TC, Model Number 7728350 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dFC, Model Number 7727717 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dFA, Model Number 7555373 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dMP, Model Number 7555365 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dBA, Model Number 7555357 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dTC, Model Number 7413078 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dFC, Model Number 7412807 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dTA, Model Number 7008605 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis TA, Model Number 7007755 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis dBC, Model Number 5917054 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis BA, Model Number 5904656 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis BC, Model Number 5904649 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis MP, Model Number 5904466 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis FA, Model Number 5904441 Terminated |
OWB | K052202 |
| Jun 12, 2019 | Siemens Medical Solutions USA, Inc AXIOM Artis FC, Model Number 5904433 Terminated |
OWB | K052202 |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis pheno-Interventional Fluoroscopic X-Ray System
Model Number: 10849000 Terminated |
OWB | K163286 |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System
Model Number: 10848355 Terminated |
OWB | K181407 |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System
Model Number: 10848354 Terminated |
OWB | K181407 |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System
Model Number: 10848353 Terminated |
OWB | K181407 |
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