SIX — Digital Pathology Image Artifact Detection Software Device Class II
FDA product code SIX covers "Digital Pathology Image Artifact Detection Software Device", a Class II medical device regulated under 21 CFR 864.3700. Submissions are reviewed by the Pathology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SIX
- Device Class
- Class II
- Regulation Number
- 864.3700
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253561 | leica biosystems imaging | Aperio iQC DX Software | August 7, 2026 |