510(k) K123596 ยท JAK System, X-Ray, Tomography, Computed
OPTIMA CT520
| Applicant | Ge Hangwei Medical Systems Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Feb 8, 2013 |
| Received | Nov 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123596
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems Open, Classified |
JAK | None listed |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems Open, Classified |
JAK | None listed |
| May 24, 2018 | GE Healthcare, LLC Optima CT 520 Terminated |
JAK | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Optima CT520 X-ray system Terminated |
JAK | None listed |
| Jan 27, 2014 | GE Healthcare, LLC GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems.
Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different an Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.