510(k) K253561 ยท SIX Digital Pathology Image Artifact Detection Software Device
Aperio iQC DX Software
| Applicant | Leica Biosystems Imaging, Inc., Vista CA, US |
| Decision | Substantially Equivalent, Aug 7, 2026 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253561
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.