510(k) K942837 ยท KPS System, Tomography, Computed, Emission
DST-XL
| Applicant | Sopha Medical Systems, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Jan 5, 1995 |
| Received | Jun 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2008 | GE Healthcare DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed tomography system. Terminated |
KPS | None listed |
| Oct 28, 2005 | General Electric Med Systems LLC Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.