510(k) K261305 ยท KPS System, Tomography, Computed, Emission
MICSI-PET
| Applicant | Microstructure Imaging, Inc., Brooklyn NY, US |
| Decision | Substantially Equivalent, Sep 11, 2026 |
| Received | Apr 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261305
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.