510(k) K081105 ยท JAK System, X-Ray, Tomography, Computed
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, May 9, 2008 |
| Received | Apr 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081105
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA:
China Only: Revolution Discovery CT Open, Classified |
JAK | None listed |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA:
China Only: Discovery CT750HD Open, Classified |
JAK | None listed |
| Mar 6, 2014 | GE Healthcare, LLC GE Healthcare, Model Number/ Description:
5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5);
5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5);
5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 Terminated |
JAK | None listed |
| Aug 9, 2013 | GE Healthcare, LLC GE LightSpeed CT750 HD
The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data take 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.