510(k) K253825 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Saige-Dx
| Applicant | DeepHealth, Inc., Somerville MA, US |
| Decision | Substantially Equivalent, Jun 15, 2026 |
| Received | Dec 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253825
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.