FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM— 510(k) K003837

Clearance details

Applicant

Ge Oec Medical Systems

Product code

Code OXO

Device class

Class 2

Regulation

21 CFR 892.1650

Advisory panel

Radiology

Date received

2000-12-12

Decision date

2001-03-12

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

6

Injury

163

Malfunction

2,099

Other

1

Total

2,269

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-2275-2023 — OEC Flexiview 8800 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-1469-2017 — OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical SystemsClass II·Terminated·GE OEC Medical Systems, Inc·20170221
• Z-0194-2015 — 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 and interventional procedures.Class II·Terminated·GE OEC Medical Systems, Inc·20141003
• Z-2027-2012 — 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 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·20071119
• Z-2221-2012 — GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.Class II·Terminated·GE OEC Medical Systems, Inc·20071019
• Z-2065-2012 — 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, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.Class I·Terminated·GE OEC Medical Systems, Inc·20061120

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003837.