510(k) DEN250007 ยท SHE Radiological Software System For Delivery Date Prediction
Delivery Date AI
| Applicant | Ultrasound AI, Greenwood Village CO, US |
| Decision | Unknown, Feb 11, 2026 |
| Received | Mar 17, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250007
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.