510(k) K253628 ยท QIH Automated Radiological Image Processing Software
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)
| Applicant | Agada Medical, Ltd., Ramat-Hasharon, IL |
| Decision | Substantially Equivalent, Jun 29, 2026 |
| Received | Nov 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253628
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.