510(k) K252477 ยท KPS System, Tomography, Computed, Emission
Hybrid Viewer (00859873006240)
| Applicant | Hermes Medical Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Sep 9, 2025 |
| Received | Aug 7, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252477
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.