510(k) K131576 ยท JAK System, X-Ray, Tomography, Computed
OPTIMA CT660
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 30, 2013 |
| Received | May 31, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system Open, Classified |
JAK | None listed |
| Jun 14, 2021 | GE Healthcare, LLC Revolution EVO, Optima CT660, Optima CT680 CT Systems. Open, Classified |
JAK | None listed |
| May 24, 2018 | GE Healthcare, LLC CT Goldseal Optima CT 600 Terminated |
JAK | None listed |
| May 24, 2018 | GE Healthcare, LLC Revolution EVO 3.6, labeled as
a. HVY WAUK;
b. LONG HINO;
c. LONG WAUK;
d. MID BJG;
e. MID WAUK. Terminated |
JAK | None listed |
| Apr 27, 2018 | GE Healthcare Japan Corporation GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the foll 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 Revolution EVO X-ray system Terminated |
JAK | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Optima CT660, CT680 X-ray system Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.