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)
Top companies in OXO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2026 | ZIEHM-ORTHOSCAN INC Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020 Open, Classified |
OXO | K243452 |
| Jun 9, 2025 | GE Medical Systems, LLC OEC 3D Open, Classified |
OXO | K203346 K233669 |
| Jun 9, 2025 | GE 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 |
OXO | K170752 K171565 +2 |
| Dec 18, 2024 | GE 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 |
OXO | K021049 K111551 +1 |
| Dec 18, 2024 | GE 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 |
OXO | K073543 K082781 +2 |
| Dec 18, 2024 | GE 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 |
OXO | K170752 K171565 +2 |
| Dec 18, 2024 | GE 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 |
OXO | K203346 K233669 |
| Jul 31, 2023 | GE 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 |
OXO | K003837 K021049 +4 |
| Jul 31, 2023 | GE OEC Medical Systems, Inc OEC 9900 Systems with 9-inch Image Intensifier Open, Classified |
OXO | K073543 K082781 +2 |
| Jul 31, 2023 | GE OEC Medical Systems, Inc OEC Flexiview 8800 Systems with 9-inch Image Intensifier Open, Classified |
OXO | K003837 |
| Jun 10, 2021 | GE 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 |
OXO | K203346 |
| May 1, 2019 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Jan 25, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 31, 2017 | Orthoscan, 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 |
OXO | K133174 |
| Aug 31, 2017 | Orthoscan, 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 |
OXO | K113708 |
| Aug 31, 2017 | Orthoscan, 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 |
OXO | K051754 |
| Aug 31, 2017 | Orthoscan, 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 |
OXO | K051754 |
| Feb 27, 2017 | GE OEC Medical Systems, Inc OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems Terminated |
OXO | K003837 |
| Jan 9, 2017 | GE 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 |
OXO | K120613 K122234 |
| Jan 9, 2017 | GE 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 |
OXO | K992506 |
| Oct 11, 2016 | GE 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 |
OXO | K123603 |
| Mar 17, 2016 | Medtronic Navigation, Inc.-Littleton Medtronic 0-arm Imaging mobile x-ray system.
Model Numbers - B1-700-00027,
B1-700-00028 Terminated |
OXO | K092564 |
| Jun 8, 2015 | GE OEC Medical Systems, Inc GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW) Terminated |
OXO | K123603 |
| Jan 13, 2015 | GE 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 |
OXO | K123603 |
| Jan 13, 2015 | GE 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 |
OXO | K123603 |
| Nov 7, 2014 | GE 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 |
OXO | K003837 |
| Nov 7, 2014 | GE 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 |
OXO | K992506 |
| Feb 28, 2014 | Medtronic 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 |
OXO | K092564 |
| Oct 24, 2013 | GE 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 |
OXO | K123603 |
| Mar 8, 2013 | Medtronic Navigation, Inc. Medtronic O-arm Imaging System
Product Usage:
image-intensified fluoroscopic x-ray system, mobile Terminated |
OXO | K092564 |
| Nov 16, 2012 | GE Healthcare, LLC GE Healthcare Brivo XR 285
Mobile general purpose radiographic imaging of the human head and body. Terminated |
OXO | None listed |
| Nov 16, 2012 | GE Healthcare, LLC GE Healthcare Optima 200amx
Mobile general purpose radiographic imaging of the human head and body. Terminated |
OXO | None listed |
| Nov 16, 2012 | GE Healthcare, LLC GE Healthcare Optima XR 220amx
Mobile general purpose radiographic imaging of the human head and body. Terminated |
OXO | None listed |
| Nov 16, 2012 | GE Healthcare, LLC GE Healthcare Optima XR 200amx with digital upgrade
Mobile general purpose radiographic imaging of the human head and body. Terminated |
OXO | None listed |
| Aug 23, 2012 | GE 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 |
OXO | K021049 K022069 +2 |
| Aug 22, 2012 | GE 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 |
OXO | K021049 K022069 +2 |
| Aug 22, 2012 | Medtronic 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 |
OXO | K092564 |
| Jul 24, 2012 | GE 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 |
OXO | K003837 |
| Jul 24, 2012 | GE 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 |
OXO | K992506 |
| Jul 18, 2012 | GE 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 |
OXO | K003837 |
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