FDA product code QKQ: Digital Pathology Image Viewing And Management Software
QKQ is the FDA product code for digital pathology image viewing and management software. It is a Class II device, regulated under 21 CFR 864.3700 and reviewed by the Pathology panel. FDA has cleared 14 510(k) submissions under QKQ, 12 in the last five years, from 12 different applicants. The average 510(k) review took 211 days (median 232); 184 days on average over the last three years.
Definition
Digital pathology image viewing and management software device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.
Classification
| Field | Value |
|---|---|
| Device name | Digital Pathology Image Viewing And Management Software |
| 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 QKQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 120 |
| 2022 | 2 | 363 |
| 2024 | 2 | 258 |
| 2025 | 7 | 195 |
| 2026 | 1 | 100 |
Compare with all 510(k) review times · Search every QKQ clearance
Top QKQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| PathAI, Inc. | 2 | 2025-06-26 |
| Paige.Ai, Inc. | 2 | 2025-01-09 |
| Proscia, Inc. | 1 | 2026-08-05 |
| Infinitt Healthcare Co., Ltd. | 1 | 2025-12-09 |
| Indica Labs, LLC | 1 | 2025-11-25 |
7 more applicants have QKQ clearances. See the full list in Caduvo.
Most recent QKQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261380 | Proscia, Inc. | Concentriq AP-Dx | 2026-08-05 | 100 |
| K243449 | Infinitt Healthcare Co., Ltd. | INFINITT DPS | 2025-12-09 | 397 |
| K252762 | Indica Labs, LLC | HALO AP Dx | 2025-11-25 | 88 |
| K243391 | PathAI, Inc. | AISight Dx | 2025-06-26 | 238 |
| K250968 | Pathpresenter Corporation | PathPresenter Clinical Viewer | 2025-06-20 | 81 |
Recalls for QKQ devices
openFDA lists no recalls for product code QKQ.
Frequently asked questions
What is FDA product code QKQ?
QKQ is the FDA product code for digital pathology image viewing and management software. It is a Class II device, regulated under 21 CFR 864.3700 and reviewed by the Pathology panel.
What device class is QKQ?
Class II, regulation 21 CFR 864.3700. Typical premarket route: 510(k).
How long does a 510(k) take for product code QKQ?
Across 14 cleared submissions the average was 211 days from receipt to decision (median 232).
Which companies have the most QKQ clearances?
PathAI, Inc. (2); Paige.Ai, Inc. (2); Proscia, Inc. (1); Infinitt Healthcare Co., Ltd. (1); Indica Labs, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QKQ
- Run a recall and safety report across every QKQ manufacturer
- Watch product code QKQ 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.
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