510(k) K251645 ยท JAK System, X-Ray, Tomography, Computed
Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Sep 26, 2025 |
| Received | May 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251645
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.