510(k) K250288 ยท QIH Automated Radiological Image Processing Software
TeraRecon Cardiovascular.Calcification.CT
| Applicant | Terarecon,Inc., Durham NC, US |
| Decision | Substantially Equivalent, Oct 23, 2025 |
| Received | Jan 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250288
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.