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) |
|---|---|---|---|
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Vision RFD. Interventional fluoroscopic x-ray system Open, Classified |
OWB | K240099 |
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Vision R. Iterventional fluoroscopic x-ray system Open, Classified |
OWB | K061203 |
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Vision FD. Interventional fluoroscopic x-ray system Open, Classified |
OWB | K240020 |
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Solo FD. Interventional fluoroscopic x-ray system Open, Classified |
OWB | K234109 |
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Solo. Digital Mobile C-arm Open, Classified |
OWB | K092438 |
| Nov 12, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Zenition 70, Model Number: 718133 Open, Classified |
OWB | K212813 |
| Nov 12, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Zenition 50, Model Number: 718096 Open, Classified |
OWB | K183101 |
| Oct 30, 2024 | Trackx Technology Inc Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking Open, Classified |
OWB | K173736 K200360 |
| Oct 22, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray Open, Classified |
OWB | K123508 |
| Sep 30, 2024 | Philips North America Azurion IGTS Fixed Systems Open, Classified |
OWB | K200917 |
| Sep 30, 2024 | Philips North America Allura Xper IGTS Fixed Systems Open, Classified |
OWB | K141979 |
| Sep 30, 2024 | Philips North America Integris-Allura IGTS Fixed Systems Open, Classified |
OWB | K002016 |
| Sep 30, 2024 | Philips North America Zenition 50 & 70 Mobile Surgery C-arm Open, Classified |
OWB | K183040 K183101 +1 |
| Sep 30, 2024 | Philips North America Veradius Unity Mobile Surgery C-arm Open, Classified |
OWB | K142708 |
| Sep 30, 2024 | Philips North America BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems. Open, Classified |
OWB | K010435 |
| Sep 30, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.
Models/Model Number:
(1) Azurion 3M12: 722063, 722221;
(2) Azurion 3M15: 722064, 722222;
(3) Azurion SM12: 7 Open, Classified |
OWB | K181830 |
| Sep 18, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 72201 Open, Classified |
OWB | K002016 |
| Sep 18, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 Allura Xper FD20 OR Table 722029 Allura Xper FD20/10 7 Open, Classified |
OWB | K141979 |
| Sep 18, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion Open, Classified |
OWB | K200917 |
| Sep 4, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224 Open, Classified |
OWB | K200917 |
| Aug 22, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013 Open, Classified |
OWB | K161563 |
| Aug 8, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number:
R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery proce Open, Classified |
OWB | K200917 |
| Aug 7, 2024 | Siemens Medical Solutions USA, Inc Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image
Model Number: 10860700 Open, Classified |
OWB | K221281 |
| Aug 7, 2024 | Siemens Medical Solutions USA, Inc LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image
Model Number: 11574100 Open, Classified |
OWB | K173639 |
| Aug 7, 2024 | Siemens Medical Solutions USA, Inc Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image.
Model Number: 10762471 Open, Classified |
OWB | K173639 |
| Aug 7, 2024 | Siemens Medical Solutions USA, Inc Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image.
Model Number: 10762472 Open, Classified |
OWB | K173639 |
| Jul 2, 2024 | Siemens AG/Siemens Healthcare GmbH ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Open, Classified |
OWB | K230950 |
| Jul 2, 2024 | Siemens AG/Siemens Healthcare GmbH ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Open, Classified |
OWB | K221516 |
| Jul 2, 2024 | Siemens AG/Siemens Healthcare GmbH ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Open, Classified |
OWB | K220432 |
| Jun 6, 2024 | Medtronic Navigation, Inc.-Littleton O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients.
Product Number: BI70002000 Open, Classified |
OWB | K151000 |
| May 24, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100. Open, Classified |
OWB | K162859 |
| May 24, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100. Open, Classified |
OWB | K162859 |
| May 24, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100. Open, Classified |
OWB | K162859 |
| May 7, 2024 | NRT X-RAY A/S Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system Open, Classified |
OWB | K173631 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K181403 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K181403 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K232344 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K232344 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K232344 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K181403 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Innova IGS 5, computed tomography x-ray system Open, Classified |
OWB | K181403 |
| Apr 18, 2024 | Siemens Medical Solutions USA, Inc Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models:
Artis zee floor- 10094135
Artis zee ceiling- 10094137
Artis zee multi-purpose- 10094139
Artis zee biplane- 10094141
Artis zeego- Open, Classified |
OWB | K181407 |
| Mar 14, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Shimadzu, Trinias, Digital Angiography System Open, Classified |
OWB | K123508 |
| Feb 22, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures
Models:
(1) 722223,
(2) 722224,
(3) 722225,
(4) 722226 Open, Classified |
OWB | K200917 |
| Feb 22, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures
Models:
(1) 722227
(2) 722228 Open, Classified |
OWB | K200917 |
| Feb 22, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures
Models:
(1) 722221
(2) 722222
(3) 722280 Open, Classified |
OWB | K200917 |
| Feb 16, 2024 | Canon Medical System, USA, INC. The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the sys Open, Classified |
OWB | K182415 |
| Feb 16, 2024 | Canon Medical System, USA, INC. The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, be Open, Classified |
OWB | K210900 |
| Feb 16, 2024 | PHILIPS 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: FlexViewing PC
Azurion Model Name - Model Number:
Azur Open, Classified |
OWB | K172822 K181830 +1 |
| Feb 16, 2024 | PHILIPS 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: FlexVision PC
Allura Xper Model Name - Model Number:
Open, Classified |
OWB | K033737 K130638 +4 |
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