510(k) K063283 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
DEFINIUM 5000 X-RAY SYSTEM
| Applicant | Sedecal., Sa., Deer Field IL, US |
| Decision | Substantially Equivalent, Nov 17, 2006 |
| Received | Oct 30, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063283
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2009 | GE Healthcare, LLC Definium 5000 X-ray System, model number 5220493 and 5220393-2 Terminated |
KPR | None listed |
| Sep 4, 2008 | GE Healthcare GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493.
The Definium 5000 System is designed to handle radiographic applications using the digital system. The system c Terminated |
KPR | None listed |
| Sep 4, 2008 | GE Healthcare GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number 5220493-2.
The Definium 5000 System is designed to handle radiographic applications using the digital system. The system Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.