510(k) K030420 ยท JAK System, X-Ray, Tomography, Computed
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
| Applicant | GE Medical Systems, Waukesha WI, US |
| Decision | Substantially Equivalent, Mar 10, 2003 |
| Received | Feb 10, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2016 | GE Medical Systems, LLC LightSpeed QX/I (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 sy Terminated |
JAK | None listed |
| Sep 21, 2015 | GE Healthcare Lightspeed 16 CT 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 Pro 16 (100kW/80kW) Models 2357739, 2357739-3, 2357739-4, 2357739-6, 2357739-7 and 2357739-8, CT Scanner systems Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.