# K253561: Aperio iQC DX Software

- Pathway: 510(k) (Traditional)
- Applicant: Leica Biosystems Imaging, Inc.
- Decided: Aug 7, 2026 after 263 days
- Product code: SIX (Digital Pathology Image Artifact Detection Software Device)
- Device class: 2
- Regulation: 21 CFR 864.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN160056 (2017). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253554: Aperio GT 450 DX; Aperio GT 180 DX, Leica Biosystems Imaging, Inc. (2026). Cleared while this submission was under review Summary page 5.

## Indications for use
Aperio iQC DX Software is an artificial intelligence-based software intended to be used as an aid in the identification of artifacts in scanned whole slide images (WSIs) of hematoxylin and eosin (H&E) and immunohistochemistry (IHC) stained, formalin-fixed paraffin embedded (FFPE) tissue that should undergo further evaluation for image quality prior to diagnostic review of the images by pathologists. Aperio iQC DX Software identifies the following artifacts: • Digital artifacts: out of focus, image striping, missing and clipped tissue • Slide preparation artifact: air bubbles • Other artifact: pen marks Aperio iQC DX Software outputs the following: • Binary ‘artifact detected’ or ‘no artifact detected’ for air bubbles, image striping, missing and clipped tissue, out of focus, and pen marks, • Overlays highlighting the location of air bubbles and out of focus artifacts only, and • Bounding boxes for missing and clipped tissue artifacts. Aperio iQC DX Software is intended to be used in conjunction with the complete in-house laboratory image quality control workflow. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images when using the Aperio iQC DX Software. Aperio iQC DX Software is not intended to be used for diagnosis, prognosis, or prediction of disease.

Source page: https://510kreport.com/device/K253561
Methodology: https://510kreport.com/methodology