510(k) K250670 ยท QIH Automated Radiological Image Processing Software
EchoConfidence (USA)
| Applicant | Mycardium AI Limited, Liverpool, GB |
| Decision | Substantially Equivalent, Jun 30, 2025 |
| Received | Mar 5, 2025 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K250670
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.