510(k) K252029 ยท QIH Automated Radiological Image Processing Software
AI-CVD
| Applicant | HeartLung Corporation, Houston TX, US |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Jun 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252029
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.