510(k) K253561
K253561 is an FDA 510(k) premarket notification submitted by Leica Biosystems Imaging, Inc. for the device "Aperio iQC DX Software". The FDA issued a decision of Substantially Equivalent on August 7, 2026. The device falls under product code SIX (Digital Pathology Image Artifact Detection Software Device), a Class II device regulated under 21 CFR 864.3700. Leica Biosystems Imaging, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2026
- Date Received
- November 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digital Pathology Image Artifact Detection Software Device
- Device Class
- Class II
- Regulation Number
- 864.3700
- Review Panel
- PA
- Submission Type
Digital Pathology Image Artifact Detection Software device is an artificial intelligence-based software intended to identify specific artifacts in scanned digital whole slide images (WSIs) of pathology slides prepared from human samples. It is intended to identify WSIs that should undergo further evaluation for image quality prior to diagnostic review of the images by pathologists. Device output is not intended for use in diagnosis, prognosis, or prediction of disease.