510(k) K993687 ยท OWB Interventional Fluoroscopic X-Ray System
UROVIEW 2800
| Applicant | Ge Dec Medical Systems, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Dec 21, 1999 |
| Received | Nov 1, 1999 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K993687
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2016 | GE OEC Medical Systems, Inc OEC UroView 2800, fluoroscopic x-ray system Terminated |
OWB | 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 OEC UroView 2800.
The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures Terminated |
OWB | None listed |
| Aug 1, 2012 | GE OEC Medical Systems, Inc UroView 2800; MDL number A349855.
Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applicatio Terminated |
JAA | None listed |
| Jun 22, 2012 | GE OEC Medical Systems, Inc OEC Uroview 2800, Model number A349855.
Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. 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 |
| Jun 30, 2007 | GE OEC Medical Systems, Inc GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. Terminated |
JAA | None listed |
| Feb 15, 2007 | GE OEC Medical Systems, Inc OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT. Terminated |
JAA | None listed |
| Feb 15, 2007 | GE OEC Medical Systems, Inc OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT. Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.