FDA product code SIX: Digital Pathology Image Artifact Detection Software Device
SIX is the FDA product code for digital pathology image artifact detection software device. It is a Class II device, regulated under 21 CFR 864.3700 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under SIX, 1 in the last five years. The average 510(k) review took 263 days (median 263); 263 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Digital Pathology Image Artifact Detection Software Device |
| Device class | Class II |
| Regulation | 21 CFR 864.3700 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
510(k) clearances per year for SIX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 263 |
Compare with all 510(k) review times · Search every SIX clearance
Top SIX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Leica Biosystems Imaging, Inc. | 1 | 2026-08-07 |
Most recent SIX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253561 | Leica Biosystems Imaging, Inc. | Aperio iQC DX Software | 2026-08-07 | 263 |
Recalls for SIX devices
openFDA lists no recalls for product code SIX.
Frequently asked questions
What is FDA product code SIX?
SIX is the FDA product code for digital pathology image artifact detection software device. It is a Class II device, regulated under 21 CFR 864.3700 and reviewed by the Pathology panel.
What device class is SIX?
Class II, regulation 21 CFR 864.3700. Typical premarket route: 510(k).
How long does a 510(k) take for product code SIX?
Across 1 cleared submissions the average was 263 days from receipt to decision (median 263).
Which companies have the most SIX clearances?
Leica Biosystems Imaging, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SIX
- Run a recall and safety report across every SIX manufacturer
- Watch product code SIX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times