510(k) K212067 ยท JAK System, X-Ray, Tomography, Computed
Deep Learning Image Reconstruction
| Applicant | Ge Healthcare Japan Corporation, Hino, JP |
| Decision | Substantially Equivalent, Sep 17, 2021 |
| Received | Jul 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212067
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.