DeviceClearance

Product code SIX— Pathology

Aperio iQC DX Software

Classification name
Digital Pathology Image Artifact Detection Software Device
Device class
Class 2
Regulation
21 CFR 864.3700
Advisory panel
Pathology
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code SIX under 21 CFR 864.3700, via openFDA

Market context for product code SIX

FDA has cleared 1 device under product code SIX, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SIX

Recent clearances under product code SIX

Data sourced from openFDA. This site is unofficial and independent of the FDA.