510(k) K041605 ยท OWB Interventional Fluoroscopic X-Ray System
PRECISION RXI ANALOG X-RAY SYSTEM
| Applicant | General Medical Merate S.P.A, Seriate (Bg), IT |
| Decision | Substantially Equivalent, Jun 30, 2004 |
| Received | Jun 15, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041605
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.