SIXClass II

Digital Pathology Image Artifact Detection Software Device

21 CFR 864.3700 / Pathology

SIX is the FDA product code for Digital Pathology Image Artifact Detection Software Device, a class II device type, regulated under 21 CFR 864.3700. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: SIX
Device name: Digital Pathology Image Artifact Detection Software Device
FDA 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.
Regulation: 21 CFR 864.3700
Device class: Class II
Review panel: Pathology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Leica Biosystems Imaging, Inc.

Recent clearances

Product code SIX

FDA records hold no clearances under product code SIX.

Recent recalls

Product code SIX

FDA records show no recalls under product code SIX.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)