510(k) K260023 ยท SHW Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
TumorSight Risk
| Applicant | SimBioSys, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Sep 25, 2026 |
| Received | Jan 5, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260023
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.