510(k) K192828 ยท JAK System, X-Ray, Tomography, Computed
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Feb 13, 2020 |
| Received | Oct 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192828
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.