K253561
- 510(k) number
- K253561
- Device name
- Aperio iQC DX Software
- Applicant
- Leica Biosystems Imaging, Inc. CA · US
- Product code
- SIX — Digital Pathology Image Artifact Detection Software
- Decision date
- 2026-08-07
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K253561.pdf
Official FDA record: K253561
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.