510(k) K082243 ยท OWB Interventional Fluoroscopic X-Ray System
PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS
| Applicant | General Medical Merate S.P.A, Greenwood Village CO, US |
| Decision | Substantially Equivalent, Nov 7, 2008 |
| Received | Aug 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2015 | GE Healthcare GE Healthcare Precision RXi 23A/32A Analog System Terminated |
OWB | None listed |
| Jul 20, 2015 | GE Healthcare GE Healthcare Precision RXi Digital system Terminated |
OWB | None listed |
| Feb 3, 2014 | GE Healthcare, LLC GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems.
The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.