510(k) K260303 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
See-Mode Augmented Reporting Tool, Breast (SMART-B)
| Applicant | See-Mode Technologies Pty, Ltd., Melbourne, AU |
| Decision | Substantially Equivalent, Jul 28, 2026 |
| Received | Jan 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260303
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.