FDA Product Code
FDA Product Code QKQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Pathology
- 21 CFR Citation
- 864.3700
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261380 | Concentriq AP-Dx | Proscia, Inc. | 2026-08-05 | Traditional | PDF ↗ |
| K243449 | INFINITT DPS | Infinitt Healthcare Co., Ltd. | 2025-12-09 | Traditional | PDF ↗ |
| K252762 | HALO AP Dx | Indica Labs, LLC | 2025-11-25 | Traditional | PDF ↗ |
| K243391 | AISight Dx | PathAI, Inc. | 2025-06-26 | Traditional | PDF ↗ |
| K250968 | PathPresenter Clinical Viewer | Pathpresenter Corporation | 2025-06-20 | Traditional | PDF ↗ |
| K250414 | CaloPix | Tribun Health | 2025-05-14 | Traditional | PDF ↗ |
| K242244 | Viewer+ | Lumea, Inc. | 2025-03-14 | Traditional | PDF ↗ |
| K241273 | FullFocus | Paige.Ai, Inc. | 2025-01-09 | Traditional | PDF ↗ |
| K240303 | MetaLite DX Digital Pathology Software | Jellox Biotech, Inc. | 2024-10-28 | Traditional | PDF ↗ |
| K233126 | aetherSlide | Aetherai Co., Ltd. | 2024-05-30 | Traditional | PDF ↗ |
| K212361 | Novo | PathAI, Inc. | 2022-08-11 | Traditional | PDF ↗ |
| K210811 | Dynamyx Digital Pathology Software | Inspirata, Inc. | 2022-03-01 | Traditional | PDF ↗ |
| K201005 | FullFocus | Paige.Ai, Inc. | 2020-07-15 | Traditional | PDF ↗ |
| K193054 | Sectra Digital Pathology Module | Sectra AB | 2020-03-31 | Traditional | PDF ↗ |
Product code QKQ · Class II · Pathology. Data: openFDA.