SIX
- Product code
- SIX
- Device name
- Digital Pathology Image Artifact Detection Software Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.3700
- Medical specialty
- Pathology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253561 | 2026-08-07 | Leica Biosystems Imaging, Inc. | Aperio iQC DX Software |
Official FDA classification page: SIX
Classification and pathway per current FDA publications. Data from openFDA (CC0).