510(k) K931049 ยท IZO Generator, High-Voltage, X-Ray, Diagnostic
ADVANTX SYSTEM
| Applicant | GE Medical Systems, Milwaukee WI, US |
| Decision | Substantially Equivalent, May 19, 1993 |
| Received | Mar 1, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931049
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2008 | GE Healthcare Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX systems.
General-purpose radiographic system Terminated |
IZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.