510(k) K040172 ยท KPS System, Tomography, Computed, Emission
MODIFICATION TO GE DISCOVERY LS SYSTEM
| Applicant | GE Medical Systems, Milwaukee WI, US |
| Decision | Substantially Equivalent, Apr 7, 2004 |
| Received | Jan 26, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040172
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2016 | GE Medical Systems, LLC Discovery LS, 2286327
LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - Th Terminated |
KPS | None listed |
| Feb 10, 2016 | GE Medical Systems, LLC Discovery ST, , 2339985
LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - T Terminated |
KPS | None listed |
| Feb 10, 2016 | GE Medical Systems, LLC LightSpeed Plus (4-slice MDAS
LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST syst Terminated |
KPS | None listed |
| Sep 21, 2015 | GE Healthcare Lightspeed 16 CT Terminated |
JAK | None listed |
| Sep 21, 2015 | GE Healthcare PET Discovery LS Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.