510(k) K024012 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
| Applicant | Ge Oec Medical Systems, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 20, 2003 |
| Received | Dec 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024012
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Sep 25, 2008 | OEC Medical Systems, Inc GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy. Terminated |
JAA | None listed |
| Sep 25, 2008 | OEC Medical Systems, Inc GE OEC 9900 Elite Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy. Terminated |
JAA | None listed |
| Sep 1, 2008 | OEC Medical Systems, Inc OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT. Terminated |
JAA | None listed |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 9800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | None listed |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC FluoroTrak 9800 PLUS, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | None listed |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 9800 MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | None listed |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 9800 Plus (Fluorotrak), Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | None listed |
| Jul 12, 2007 | GE OEC Medical Systems, Inc GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | None listed |
| Jun 30, 2007 | GE OEC Medical Systems, Inc GE OEC 9800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. Terminated |
JAA | None listed |
| Mar 22, 2007 | GE OEC Medical Systems, Inc OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery. Terminated |
JAA | None listed |
| Mar 22, 2007 | GE OEC Medical Systems, Inc OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System, Terminated |
JAA | None listed |
| Mar 22, 2007 | GE OEC Medical Systems, Inc OEC 9800 Plus Fluoroscopic X-ray System, Terminated |
JAA | None listed |
| Mar 22, 2007 | GE OEC Medical Systems, Inc OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System, Terminated |
JAA | None listed |
| Oct 3, 2006 | GE OEC Medical Systems, Inc GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems) Terminated |
JAA | None listed |
| Sep 30, 2006 | GE OEC Medical Systems, Inc GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc. Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.