OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM— 510(k) K021049

Clearance details

Applicant

Ge Oec Medical Systems

Product code

Code OWB

Device class

Class 2

Regulation

21 CFR 892.1650

Advisory panel

Radiology

Date received

2002-04-01

Decision date

2002-04-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Salt Lake City, UT, US

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• K073543 — OEC 9900 ELITE2008-05-02
• K061953 — 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS2006-08-15
• K052039 — GE OEC ALTITUDE2005-08-11
• K024012 — OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM2003-03-20
• K022069 — OEC FLUOROTRAK 9800 PLUS2002-09-17

Death

49

Injury

340

Malfunction

36,973

Total

37,362

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2341-2025 — GE HealthCare OEC 9800.Class II·Ongoing·GE Medical Systems, LLC·20250702
• Z-0706-2025 — 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 interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.Class II·Ongoing·GE OEC Medical Systems, Inc·20241121
• Z-2276-2023 — OEC 9800 Systems with 9-inch Image IntensifierClass II·Ongoing·GE OEC Medical Systems, Inc·20230515
• Z-2279-2023 — 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, OEC 9800, and OEC 9900 SystemsClass II·Ongoing·GE OEC Medical Systems, Inc·20230515
• Z-2629-2016 — OEC 9800, fluoroscopic x-ray systemClass II·Terminated·GE OEC Medical Systems, Inc·20160722
• Z-0195-2015 — 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.Class II·Terminated·GE OEC Medical Systems, Inc·20141003
• Z-2241-2012 — 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 the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.Class II·Terminated·GE OEC Medical Systems, Inc·20100426
• Z-2240-2012 — 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 systems include features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and are also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. The systems may be used for other imaging applications at the physician's discretion.Class II·Terminated·GE OEC Medical Systems, Inc·20091106
• Z-2262-2012 — 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 include 00-902260-01 and 00-883654-01.Class II·Terminated·GE OEC Medical Systems, Inc·20081010
• Z-2038-2012 — 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-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.Class I·Terminated·GE OEC Medical Systems, Inc·20080222
• Z-2026-2012 — 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 interventional procedures. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.Class II·Terminated·GE OEC Medical Systems, Inc·20071119
• Z-2125-2012 — 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. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.Class II·Terminated·GE OEC Medical Systems, Inc·20070327

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021049.