510(k) K254001 ยท KPS System, Tomography, Computed, Emission
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
| Applicant | Spectrum Dynamics Medical, Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Jan 13, 2026 |
| Received | Dec 15, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254001
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.