QKQ
- Product code
- QKQ
- Device name
- Digital Pathology Image Viewing And Management Software
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.3700
- Medical specialty
- Pathology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 14 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261380 | 2026-08-05 | Proscia, Inc. | Concentriq AP-Dx | |
| K243449 | 2025-12-09 | Infinitt Healthcare Co., Ltd. | INFINITT DPS | |
| K252762 | 2025-11-25 | Indica Labs, LLC | HALO AP Dx | |
| K243391 | 2025-06-26 | PathAI, Inc. | AISight Dx | |
| K250968 | 2025-06-20 | Pathpresenter Corporation | PathPresenter Clinical Viewer | |
| K250414 | 2025-05-14 | Tribun Health | CaloPix | |
| K242244 | 2025-03-14 | Lumea, Inc. | Viewer+ | |
| K241273 | 2025-01-09 | Paige.Ai, Inc. | FullFocus | |
| K240303 | 2024-10-28 | Jellox Biotech, Inc. | MetaLite DX Digital Pathology Software | |
| K233126 | 2024-05-30 | Aetherai Co., Ltd. | aetherSlide |
Official FDA classification page: QKQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).