510(k) K253796 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Lunit INSIGHT DBT (V1.2)
| Applicant | Lunit, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Mar 26, 2026 |
| Received | Nov 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253796
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.