510(k) K243158 ยท QIH Automated Radiological Image Processing Software
TeraRecon Aorta.CT (1.1.0)
| Applicant | Terarecon,Inc., Durham NC, US |
| Decision | Substantially Equivalent, Jan 23, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243158
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.