System, X-Ray, Fluoroscopic, Image-Intensified
Regulation 892.1650
1510(k)s in 12 months (300 all time)
1recalls in 12 months (223 all time)
197recalls that name a 510(k)
Top companies in JAA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2008 | GE Healthcare GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA
The product is used for performing general R&F, radiology, fluoroscopy, interven Terminated |
JAA | K041605 |
| Sep 19, 2008 | GE Healthcare GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA
The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures Terminated |
JAA | K033486 |
| Sep 19, 2008 | GE Healthcare GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA
The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures Terminated |
JAA | K033486 |
| Sep 19, 2008 | GE Healthcare GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA
The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures Terminated |
JAA | K033486 |
| Sep 19, 2008 | GE Healthcare GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 2345243, 2401181, 2403790, 2403791, 2404103, 2407276, 2407576, 5179385, 2289299-2, 2290479-2, 2345260-12, 234526 Terminated |
JAA | K011624 |
| Sep 18, 2008 | GE Healthcare GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A. Terminated |
JAA | K011624 |
| Sep 18, 2008 | GE Healthcare GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A. Terminated |
JAA | K051967 |
| Sep 4, 2008 | GE Healthcare GE Precision 500D Classical Radiographic-Fluoroscopic
X-ray System.
Model #2289299-2, with console computer and touch screen fullly integrated. the GE Precision 500D Classical Radiographic-Fluoroscop Terminated |
JAA | K011624 |
| Sep 1, 2008 | OEC Medical Systems, Inc OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT. Terminated |
JAA | K041932 |
| 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 | K021049 K022069 +1 |
| Aug 24, 2008 | GE Healthcare GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System. It is a remote analog R&F system consisting of a tilting table with integrated spot film device, and 50KW or 65 kW pulsing gen Terminated |
JAA | K041605 |
| Aug 24, 2008 | GE Healthcare GE Healthcare Precision RXi Digital Remote X-Ray Imaging R&F System. It is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 89 kW pulsing generator and high h Terminated |
JAA | K041605 |
| Aug 24, 2008 | GE Healthcare GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System. It is a remote analog R&F system consisting of a tilting table with integrated spot film device, 65 kW pulsing generator and high Terminated |
JAA | K041605 |
| Aug 2, 2008 | GE Healthcare Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic x-ray system; ; Model Number: 5117866-27. Terminated |
JAA | K011624 |
| May 28, 2008 | Philips Medical Systems North America Co. Phillips MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems,
Bothell, WA, 98021 Terminated |
JAA | K050151 |
| Mar 15, 2008 | GE OEC Medical Systems, Inc GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700, GE Healthcare, Surgery, Salt Lake City, Utah Terminated |
JAA | K000221 |
| Mar 15, 2008 | GE OEC Medical Systems, Inc GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah. Terminated |
JAA | K970063 |
| Nov 10, 2007 | Philips Medical Systems North America Co. Phillips Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option Terminated |
JAA | None listed |
| Nov 10, 2007 | Philips Medical Systems North America Co. Phillips Philips Medical System - BV Pulsera Mobile C-arms with Remote Control Option, (Release 2) Terminated |
JAA | None listed |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | K041932 |
| 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 | K021049 K022069 +1 |
| 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 | K021049 K022069 +1 |
| 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 | K021049 K022069 +1 |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | K041932 |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | K003837 |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 9800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | K021049 K022069 +1 |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 9900 Elite image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | K041932 |
| Jul 12, 2007 | GE OEC Medical Systems, Inc GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | K024012 |
| Jul 12, 2007 | GE OEC Medical Systems, Inc GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | K041931 |
| Jul 3, 2007 | OEC Medical Systems, Inc OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake City, Utah. Terminated |
JAA | K992506 |
| Jun 30, 2007 | GE OEC Medical Systems, Inc GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. Terminated |
JAA | K993687 |
| Jun 30, 2007 | GE OEC Medical Systems, Inc GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. Terminated |
JAA | K992506 |
| Jun 30, 2007 | GE OEC Medical Systems, Inc GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah Terminated |
JAA | K003837 |
| Jun 30, 2007 | GE OEC Medical Systems, Inc GE OEC 9800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. Terminated |
JAA | K024012 |
| Jun 30, 2007 | GE OEC Medical Systems, Inc GE OEC 9900 Elite Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. Terminated |
JAA | K041931 |
| Mar 22, 2007 | GE OEC Medical Systems, Inc OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System, Terminated |
JAA | K021049 K022069 +1 |
| Mar 22, 2007 | GE OEC Medical Systems, Inc OEC 9800 Plus Fluoroscopic X-ray System, Terminated |
JAA | K021049 K022069 +1 |
| Mar 22, 2007 | GE OEC Medical Systems, Inc OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System, Terminated |
JAA | K021049 K022069 +1 |
| Mar 22, 2007 | GE OEC Medical Systems, Inc OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery. Terminated |
JAA | K021049 K022069 +1 |
| 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 | K993687 |
| 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 | K993687 |
| Oct 25, 2006 | GE OEC Medical Systems, Inc GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc. Terminated |
JAA | K041931 |
| Oct 14, 2006 | GE OEC Medical Systems, Inc OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc. Terminated |
JAA | K041931 |
| Oct 3, 2006 | GE OEC Medical Systems, Inc GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems) Terminated |
JAA | K024012 |
| Sep 30, 2006 | GE Healthcare GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 80 kW pulsing generato Terminated |
JAA | K041605 |
| Sep 30, 2006 | GE OEC Medical Systems, Inc RUS Tool Version Software Terminated |
JAA | None listed |
| Sep 30, 2006 | GE OEC Medical Systems, Inc GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc. Terminated |
JAA | K024012 |
| Sep 30, 2006 | GE OEC Medical Systems, Inc GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc. Terminated |
JAA | K041931 |
| Sep 30, 2006 | GE OEC Medical Systems,Inc MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system. Terminated |
JAA | K992506 |
| Sep 22, 2006 | General Electric Med Systems LLC GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an X-ray generator; angulating table with x-ray Tube, collimator and image intensifier; wall stand Terminated |
JAA | K011624 |
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