510(k) K240827 ยท KPS System, Tomography, Computed, Emission
SET-5002
| Applicant | Shimadzu Corporation Medical Systems Division, Kyoto, JP |
| Decision | Substantially Equivalent, May 24, 2024 |
| Received | Mar 26, 2024 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K240827
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.