510(k) K013561 ยท JAK System, X-Ray, Tomography, Computed
LIGHTSPEED 4.0 CT SCANNER SYSTEM
| Applicant | GE Medical Systems, New Berlin WI, US |
| Decision | Substantially Equivalent, Nov 8, 2001 |
| Received | Oct 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013561
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2016 | GE Medical Systems, LLC LightSpeed Ultra (8-slice MDAS), 5120327-3
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 Dis Terminated |
JAK | None listed |
| Sep 21, 2015 | GE Healthcare Lightspeed 16 CT Terminated |
JAK | None listed |
| May 15, 2015 | GE Healthcare CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985.
Designed to be a head and whole body CT scanner utilizing a new solid state detector. Terminated |
JAK | None listed |
| Apr 29, 2013 | GE Healthcare, LLC GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD.
Intended to produce cross-sectional images of the body by computer reconstruction of x-ray tr Terminated |
JAK | None listed |
| Jan 8, 2004 | General Electric Med Systems Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630. Terminated |
IYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.