510(k) K913485 ยท JAK System, X-Ray, Tomography, Computed
CT SYTEC 8000
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jan 23, 1992 |
| Received | Aug 6, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2009 | GE Medical Systems, LLC Sytec 6000, Sytec 8000, and Lemage/ProSeed/ProSpeed families.
The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.