510(k) K040372 ยท JAK System, X-Ray, Tomography, Computed
LIGHTSPEED 7.0 CT SCANNER SYSTEM
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Mar 1, 2004 |
| Received | Feb 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040372
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2017 | GE Healthcare, LLC GE Healthcare LightSpeed VCT X-ray system 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 |
| May 15, 2007 | GE Healthcare GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner System. Terminated |
JAK | None listed |
| May 15, 2007 | GE Healthcare GE LightSpeed VCT Select / LightSpeed Pro32, Model 5126093, CT Scanner system. Terminated |
JAK | None listed |
| Feb 15, 2007 | GE Healthcare The LightSpeed VCT System is intended 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.