510(k) K941191 ยท IZH System, X-Ray, Mammographic
REAL TIME STEREOTIX
| Applicant | GE Medical Systems, Milwaukee WI, US |
| Decision | Substantially Equivalent, May 11, 1995 |
| Received | Mar 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941191
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2008 | GE Healthcare GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senograph Terminated |
IZH | None listed |
| Sep 26, 2008 | GE Healthcare GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senograph Terminated |
IZH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.