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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)
Dec 2, 2024Orthoscan, Inc.
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Open, Classified
OWBK240099
Dec 2, 2024Orthoscan, Inc.
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Open, Classified
OWBK061203
Dec 2, 2024Orthoscan, Inc.
Ziehm Vision FD. Interventional fluoroscopic x-ray system
Open, Classified
OWBK240020
Dec 2, 2024Orthoscan, Inc.
Ziehm Solo FD. Interventional fluoroscopic x-ray system
Open, Classified
OWBK234109
Dec 2, 2024Orthoscan, Inc.
Ziehm Solo. Digital Mobile C-arm
Open, Classified
OWBK092438
Nov 12, 2024PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Zenition 70, Model Number: 718133
Open, Classified
OWBK212813
Nov 12, 2024PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Zenition 50, Model Number: 718096
Open, Classified
OWBK183101
Oct 30, 2024Trackx 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
OWBK173736
K200360
Oct 22, 2024SHIMADZU 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
OWBK123508
Sep 30, 2024Philips North America
Azurion IGTS Fixed Systems
Open, Classified
OWBK200917
Sep 30, 2024Philips North America
Allura Xper IGTS Fixed Systems
Open, Classified
OWBK141979
Sep 30, 2024Philips North America
Integris-Allura IGTS Fixed Systems
Open, Classified
OWBK002016
Sep 30, 2024Philips North America
Zenition 50 & 70 Mobile Surgery C-arm
Open, Classified
OWBK183040
K183101 +1
Sep 30, 2024Philips North America
Veradius Unity Mobile Surgery C-arm
Open, Classified
OWBK142708
Sep 30, 2024Philips North America
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Open, Classified
OWBK010435
Sep 30, 2024PHILIPS 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
OWBK181830
Sep 18, 2024PHILIPS 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
OWBK002016
Sep 18, 2024PHILIPS 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
OWBK141979
Sep 18, 2024PHILIPS 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
OWBK200917
Sep 4, 2024PHILIPS 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
OWBK200917
Aug 22, 2024PHILIPS 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
OWBK161563
Aug 8, 2024PHILIPS 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
OWBK200917
Aug 7, 2024Siemens 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
OWBK221281
Aug 7, 2024Siemens 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
OWBK173639
Aug 7, 2024Siemens 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
OWBK173639
Aug 7, 2024Siemens 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
OWBK173639
Jul 2, 2024Siemens 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
OWBK230950
Jul 2, 2024Siemens 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
OWBK221516
Jul 2, 2024Siemens 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
OWBK220432
Jun 6, 2024Medtronic 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
OWBK151000
May 24, 2024PHILIPS 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
OWBK162859
May 24, 2024PHILIPS 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
OWBK162859
May 24, 2024PHILIPS 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
OWBK162859
May 7, 2024NRT 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
OWBK173631
May 6, 2024GE Medical Systems, SCS
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Open, Classified
OWBK181403
May 6, 2024GE Medical Systems, SCS
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Open, Classified
OWBK181403
May 6, 2024GE Medical Systems, SCS
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
Open, Classified
OWBK232344
May 6, 2024GE Medical Systems, SCS
GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
Open, Classified
OWBK232344
May 6, 2024GE Medical Systems, SCS
GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
Open, Classified
OWBK232344
May 6, 2024GE Medical Systems, SCS
GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
Open, Classified
OWBK181403
May 6, 2024GE Medical Systems, SCS
GE Healthcare Innova IGS 5, computed tomography x-ray system
Open, Classified
OWBK181403
Apr 18, 2024Siemens 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
OWBK181407
Mar 14, 2024SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Shimadzu, Trinias, Digital Angiography System
Open, Classified
OWBK123508
Feb 22, 2024PHILIPS 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
OWBK200917
Feb 22, 2024PHILIPS 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
OWBK200917
Feb 22, 2024PHILIPS 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
OWBK200917
Feb 16, 2024Canon 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
OWBK182415
Feb 16, 2024Canon 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
OWBK210900
Feb 16, 2024PHILIPS 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
OWBK172822
K181830 +1
Feb 16, 2024PHILIPS 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
OWBK033737
K130638 +4

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