Company ยท US
GE OEC Medical Systems, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2024. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
93recalls (0 in 12 months)
92recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 41 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 28 |
| OWB | Interventional Fluoroscopic X-Ray System | 21 |
| LLZ | System, Image Processing, Radiological | 17 |
| IZL | System, X-Ray, Mobile | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 |
| IZI | System, X-Ray, Angiographic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 28, 2024 | K233669 | OEC 3D Ge Oec Medical Systems, Inc. | OXO |
| Mar 5, 2021 | K203346 | OEC 3D Ge Oec Medical Systems, Inc. | OXO |
| Nov 8, 2019 | K192819 | OEC Elite Ge Oec Medical Systems, Inc. | OXO |
| Nov 16, 2017 | K172550 | OEC Elite Ge Oec Medical Systems, Inc. | OXO |
| Aug 10, 2017 | K171565 | OEC Elite Ge Oec Medical Systems, Inc. | OWB |
| May 1, 2014 | K132027 | OEC 9800 PLUS Ge Oec Medical Systems, Inc. | OWB |
| Oct 4, 2011 | K111551 | OEC(R) 9800, OEC(R) 9800 PLUS Ge Oec Medical Systems, Inc. | OWB |
| May 2, 2008 | K073543 | OEC 9900 ELITE Ge Oec Medical Systems | OWB |
| Aug 15, 2006 | K061953 | 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS Ge Oec Medical Systems | OWB |
| Aug 11, 2005 | K052039 | GE OEC ALTITUDE Ge Oec Medical Systems | IZI |
| Jul 7, 2005 | K051490 | GE OEC EVERVIEW 7500 Ge Oec Medical Systems, Inc. | OXO |
| Dec 22, 2004 | K043076 | GE OEC FLUOROSTAR Ge Oec Medical Systems, Inc. | OWB |
| Aug 26, 2004 | K041931 | OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION Ge Oec Medical Systems, Inc. | OWB |
| Aug 18, 2004 | K041932 | OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM Ge Oec Medical Systems, Inc. | OWB |
| Mar 20, 2003 | K024012 | OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems | JAA |
| Sep 17, 2002 | K022069 | OEC FLUOROTRAK 9800 PLUS Ge Oec Medical Systems | OWB |
| Apr 17, 2002 | K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems | OWB |
| Mar 12, 2001 | K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems | OXO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 Elite Systems with 9-inch Image Intensifier Open, Classified |
OWB | K170752 K171565 +2 |
| 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 9800 Systems with 9-inch Image Intensifier Open, Classified |
OWB | K021049 K111551 +1 |
| 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 Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventi Terminated |
OWB | K170752 K171565 +2 |
| 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 |
| Feb 27, 2017 | GE OEC Medical Systems, Inc OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems Terminated |
OXO | K003837 |
| Jan 20, 2017 | GE OEC Medical Systems, Inc OEC 9900 Elite. MDL Numbers: D148942, D155043 Terminated |
OWB | K120613 K122234 |
| Jan 20, 2017 | GE OEC Medical Systems, Inc OEC 9800. MDL Numbers: D222250, D141598 Terminated |
OWB | K111551 K132027 |
| 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 |
| Jan 9, 2017 | GE OEC Medical Systems, Inc OEC 9800. MDL Numbers: D222250, D141598
The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applic Terminated |
OWB | K111551 K132027 |
| 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 |
| Jul 22, 2016 | GE OEC Medical Systems, Inc OEC 9800, fluoroscopic x-ray system Terminated |
OWB | K021049 K022069 +3 |
| Jul 22, 2016 | GE OEC Medical Systems, Inc OEC UroView 2800, fluoroscopic x-ray system Terminated |
OWB | K993687 |
| 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 Series OEC 9800.
The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures. Terminated |
OWB | K021049 K022069 +2 |
| 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 |
| Nov 7, 2014 | GE OEC Medical Systems, Inc OEC UroView 2800.
The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures Terminated |
OWB | K993687 |
| Apr 16, 2014 | GE OEC Medical Systems, Inc The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventiona Terminated |
OWB | K061953 K073543 +1 |
| Dec 17, 2013 | GE OEC Medical Systems, Inc InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA), Terminated |
LLZ | K960330 |
| Aug 28, 2012 | GE OEC Medical Systems, Inc OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems a Terminated |
LLZ | K960330 K981998 +4 |
| 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 OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical con Terminated |
LLZ | K003510 |
| 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 | GE OEC Medical Systems, Inc 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The Terminated |
JAA | K021049 K022069 +1 |
| Aug 17, 2012 | GE OEC Medical Systems, Inc GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT.
Mobile fluoroscopic examination of human anatomy. Terminated |
JAA | K003837 |
| Aug 8, 2012 | GE OEC Medical Systems, Inc Radiological Image Processing System
The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benef Terminated |
LLZ | K994270 |
| Aug 1, 2012 | GE OEC Medical Systems, Inc UroView 2800; MDL number A349855.
Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applicatio Terminated |
JAA | K993687 |
| Aug 1, 2012 | GE OEC Medical Systems, Inc OEC MiniView 6800 Mobile; MDL number A349855.
Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including Terminated |
IZL | K992506 |
| Aug 1, 2012 | GE OEC Medical Systems, Inc OEC 9800 Plus Digital; MDL number A349855.
Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinica Terminated |
IZL | K021049 |
| Jul 24, 2012 | GE OEC Medical Systems, Inc OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system.
The OEC 9800 is designed to provide fluoroscopic and spot- Terminated |
JAA | K021049 K022069 +1 |
| 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 |
| Jul 18, 2012 | GE OEC Medical Systems, Inc OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and intervention Terminated |
JAA | K021049 K022069 +1 |
| Jul 18, 2012 | GE OEC Medical Systems, Inc OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures.
The system is an aid to lo Terminated |
JAA | K041932 |
| Jul 12, 2012 | GE OEC Medical Systems, Inc InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus.
Product Usage: Usage:
The system is an aid to locate anatomical structures during op Terminated |
LLZ | K040050 |
| Jul 11, 2012 | GE OEC Medical Systems, Inc The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit.
The Axce Terminated |
HAW | K051734 |
| Jun 22, 2012 | GE OEC Medical Systems, Inc OEC Uroview 2800, Model number A349855.
Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Terminated |
JAA | K993687 |
| Apr 11, 2011 | GE OEC Medical Systems, Inc Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116.
Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500 Terminated |
LLZ | K040050 |
| Apr 11, 2011 | GE OEC Medical Systems, Inc Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116.
Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT25 Terminated |
LLZ | K040050 |
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