510(k) K000976 ยท IZH System, X-Ray, Mammographic
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
| Applicant | Instrumentarium Imaging, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jun 1, 2000 |
| Received | Mar 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000976
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2007 | General Electric Med Systems LLC Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. Terminated |
IZH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.