510(k) K203169 ยท JAK System, X-Ray, Tomography, Computed
Revolution Ascend
| Applicant | Ge Healthcare Japan Corporation, Hino, JP |
| Decision | Substantially Equivalent, Nov 20, 2020 |
| Received | Oct 23, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203169
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2021 | GE Healthcare, LLC The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumet Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.