510(k) K060052 ยท JAK System, X-Ray, Tomography, Computed
GE LIGHTSPEED XTRA CT SCANNER SYSTEM
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Apr 19, 2006 |
| Received | Jan 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060052
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Lightspeed RT16 X-ray system Terminated |
JAK | None listed |
| May 15, 2007 | GE Healthcare GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems. Terminated |
JAK | None listed |
| Feb 15, 2007 | GE Healthcare The LightSpeed RT16 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. The system is capable of generating images for the guidance of minimally invasive pr Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.