510(k) K213504 ยท JAK System, X-Ray, Tomography, Computed
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jun 16, 2022 |
| Received | Nov 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213504
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.