510(k) K260320 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Lunit INSIGHT MMG (v1.1.10)
| Applicant | Lunit, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Apr 23, 2026 |
| Received | Jan 30, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260320
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.