510(k) K003837 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
| Applicant | Ge Oec Medical Systems, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 12, 2001 |
| Received | Dec 12, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2023 | GE OEC Medical Systems, Inc OEC Flexiview 8800 Systems with 9-inch Image Intensifier Open, Classified |
OXO | 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 |
| Feb 27, 2017 | GE OEC Medical Systems, Inc OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems Terminated |
OXO | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | None listed |
| Jun 30, 2007 | GE OEC Medical Systems, Inc GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.