510(k) K253963 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Cubresa BrainPET
| Applicant | Cubresa, Inc., Winnipeg, CA |
| Decision | Substantially Equivalent, Jul 17, 2026 |
| Received | Dec 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253963
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.