510(k) K193170 ยท JAK System, X-Ray, Tomography, Computed
Deep Learning Image Reconstruction
| Applicant | Ge Healthcare Japan Corporation, Hino, JP |
| Decision | Substantially Equivalent, Dec 13, 2019 |
| Received | Nov 15, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193170
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.