510(k) K211733 ยท QFM Radiological Computer-Assisted Prioritization Software For Lesions
Lunit INSIGHT CXR Triage
| Applicant | Lunit, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Nov 10, 2021 |
| Received | Jun 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211733
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.