510(k) K890348 ยท IZI System, X-Ray, Angiographic
LC, CARDIAC POSITIONER #B5078A
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Feb 27, 1989 |
| Received | Jan 23, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890348
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | General Electric Med Systems Advantx 1 LC1 Model 46-279781P1 Angiographic X-ray System Terminated |
IZI | None listed |
| Jul 20, 2004 | General Electric Med Systems Advantx 1 LC1 Model 45258230 Angiographic X-ray System Terminated |
IZI | None listed |
| Jul 20, 2004 | General Electric Med Systems Advantx 1 LC2 Model 45562281 Angiographic X-ray System Terminated |
IZI | None listed |
| Jul 20, 2004 | General Electric Med Systems Advantx 1 LC2 Model 2105657 Angiographic X-ray System Terminated |
IZI | None listed |
| Jul 20, 2004 | General Electric Med Systems Advantx 1 SC Model 36006617 Angiographic X-ray System Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.