510(k) K253532 ยท QIH Automated Radiological Image Processing Software
TruSPECT Processing Station
| Applicant | Spectrum Dynamics Medical, Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Dec 30, 2025 |
| Received | Nov 13, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253532
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.