510(k) K260811 ยท QIH Automated Radiological Image Processing Software
Heartvue.Proton
| Applicant | Heartvue.ai, Inc., Brentwood TN, US |
| Decision | Substantially Equivalent, Aug 26, 2026 |
| Received | Mar 12, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260811
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.