510(k) K110227 ยท JAK System, X-Ray, Tomography, Computed
OPTIMA CT660
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Jul 20, 2011 |
| Received | Jan 25, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110227
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2018 | GE Healthcare, LLC CT Goldseal Optima CT 600 Terminated |
JAK | None listed |
| Apr 27, 2018 | GE Healthcare Japan Corporation GE Healthcare Optima CT660. Sold under the following product names:
BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200,
BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL,
CT GOLDSEAL OPTIM Terminated |
JAK | None listed |
| Apr 27, 2018 | GE Healthcare Japan Corporation GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the following product names: Terminated |
JAK | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Optima CT660, CT680 X-ray system Terminated |
JAK | None listed |
| Oct 17, 2013 | GE Healthcare, LLC GE, Optima CT660.
Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.