510(k) K213938 ยท JAK System, X-Ray, Tomography, Computed
Revolution Ascend
| Applicant | Ge Healthcare Japan Corporation, Hino, JP |
| Decision | Substantially Equivalent, Feb 4, 2022 |
| Received | Dec 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213938
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2026 | GE Medical Systems, LLC Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 Open, Classified |
JAK | None listed |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.