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Panels › Radiology › Product code OXO · Class 2

Image-Intensified Fluoroscopic X-Ray System, Mobile

Regulation 892.1650

4510(k)s in 12 months (82 all time)
1recalls in 12 months (50 all time)
46recalls that name a 510(k)
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Top companies in OXO

DateFirm and productCodeLinked 510(k)
Oct 23, 2026ZIEHM-ORTHOSCAN INC
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Open, Classified
OXOK243452
Jun 9, 2025GE Medical Systems, LLC
OEC 3D
Open, Classified
OXOK203346
K233669
Jun 9, 2025GE Medical Systems, LLC
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, intervent
Open, Classified
OXOK170752
K171565 +2
Dec 18, 2024GE OEC Medical Systems, Inc
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interve
Open, Classified
OXOK021049
K111551 +1
Dec 18, 2024GE OEC Medical Systems, Inc
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnost
Open, Classified
OXOK073543
K082781 +2
Dec 18, 2024GE OEC Medical Systems, Inc
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools
Open, Classified
OXOK170752
K171565 +2
Dec 18, 2024GE OEC Medical Systems, Inc
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is
Open, Classified
OXOK203346
K233669
Jul 31, 2023GE OEC Medical Systems, Inc
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800,
Open, Classified
OXOK003837
K021049 +4
Jul 31, 2023GE OEC Medical Systems, Inc
OEC 9900 Systems with 9-inch Image Intensifier
Open, Classified
OXOK073543
K082781 +2
Jul 31, 2023GE OEC Medical Systems, Inc
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Open, Classified
OXOK003837
Jun 10, 2021GE OEC Medical Systems, Inc
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, inte
Terminated
OXOK203346
May 1, 2019Medtronic Navigation, Inc.-Littleton
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM AS
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoro
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopi
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluorosco
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic a
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluo
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic an
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluorosco
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic an
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic an
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3
Terminated
OXOK092564
Jan 25, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS
Terminated
OXOK092564
Aug 31, 2017Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures a
Terminated
OXOK133174
Aug 31, 2017Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and
Terminated
OXOK113708
Aug 31, 2017Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and
Terminated
OXOK051754
Aug 31, 2017Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and
Terminated
OXOK051754
Feb 27, 2017GE OEC Medical Systems, Inc
OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
Terminated
OXOK003837
Jan 9, 2017GE OEC Medical Systems, Inc
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical appli
Terminated
OXOK120613
K122234
Jan 9, 2017GE OEC Medical Systems, Inc
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited
Terminated
OXOK992506
Oct 11, 2016GE OEC Medical Systems, Inc
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image g
Terminated
OXOK123603
Mar 17, 2016Medtronic Navigation, Inc.-Littleton
Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
Terminated
OXOK092564
Jun 8, 2015GE OEC Medical Systems, Inc
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Terminated
OXOK123603
Jan 13, 2015GE OEC Medical Systems, Inc
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Terminated
OXOK123603
Jan 13, 2015GE OEC Medical Systems, Inc
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Terminated
OXOK123603
Nov 7, 2014GE OEC Medical Systems, Inc
FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical an
Terminated
OXOK003837
Nov 7, 2014GE OEC Medical Systems, Inc
OEC MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and
Terminated
OXOK992506
Feb 28, 2014Medtronic Navigation, Inc.
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intend
Terminated
OXOK092564
Oct 24, 2013GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guida
Terminated
OXOK123603
Mar 8, 2013Medtronic Navigation, Inc.
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Terminated
OXOK092564
Nov 16, 2012GE Healthcare, LLC
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Terminated
OXONone listed
Nov 16, 2012GE Healthcare, LLC
GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
Terminated
OXONone listed
Nov 16, 2012GE Healthcare, LLC
GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
Terminated
OXONone listed
Nov 16, 2012GE Healthcare, LLC
GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
Terminated
OXONone listed
Aug 23, 2012GE OEC Medical Systems, Inc
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers i
Terminated
OXOK021049
K022069 +2
Aug 22, 2012GE OEC Medical Systems, Inc
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as
Terminated
OXOK021049
K022069 +2
Aug 22, 2012Medtronic Navigation, Inc.
Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Terminated
OXOK092564
Jul 24, 2012GE OEC Medical Systems, Inc
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic,
Terminated
OXOK003837
Jul 24, 2012GE OEC Medical Systems, Inc
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualizatio
Terminated
OXOK992506
Jul 18, 2012GE OEC Medical Systems, Inc
OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic an
Terminated
OXOK003837

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