510(k) K021049 ยท OWB Interventional Fluoroscopic X-Ray System
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
| Applicant | Ge Oec Medical Systems, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Apr 17, 2002 |
| Received | Apr 1, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021049
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | GE Medical Systems, LLC GE HealthCare OEC 9800. Open, Classified |
OWB | None listed |
| 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 | None listed |
| Jul 31, 2023 | GE OEC Medical Systems, Inc OEC 9800 Systems with 9-inch Image Intensifier Open, Classified |
OWB | None listed |
| 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 | None listed |
| Jul 22, 2016 | GE OEC Medical Systems, Inc OEC 9800, fluoroscopic x-ray system Terminated |
OWB | None listed |
| 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 | 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 | 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 |
| 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 | 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 1, 2009 | GE Medical Systems, LLC GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA. Terminated |
MMP | None listed |
| Sep 1, 2009 | GE Medical Systems, LLC Sterile, Drape, Headset, Lower, Part Number 888944-01. Terminated |
MMP | None listed |
| Sep 1, 2009 | GE Medical Systems, LLC Sterile, Drape, Headset, Upper, Part Number 888945-01. Terminated |
MMP | None listed |
| Sep 1, 2009 | GE Medical Systems, LLC Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper). Terminated |
MMP | None listed |
| Aug 14, 2009 | GE Medical Systems, LLC GE Healthcare, Drapes and Sterile Covers
PART NUMBER DESCRIPTION
00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL
00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AN Terminated |
MMP | 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 |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.