510(k) K260086 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
CadAI-B Dx
| Applicant | BeamWorks, Inc., Daegu, KR |
| Decision | Substantially Equivalent, Aug 12, 2026 |
| Received | Jan 12, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260086
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.