510(k) K231470 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Lunit INSIGHT DBT
| Applicant | Lunit, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Nov 6, 2023 |
| Received | May 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231470
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.