Digital Pathology Image Viewing And Management Software
Regulation 864.3700
3510(k)s in 12 months (14 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QKQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Paige.Ai, Inc. | 2 | 0 |
| PathAI, Inc. | 2 | 0 |
| Aetherai Co., Ltd. | 1 | 0 |
| Indica Labs, LLC | 1 | 0 |
| Infinitt Healthcare Co., Ltd. | 1 | 0 |
| Inspirata, Inc. | 1 | 0 |
| Jellox Biotech, Inc. | 1 | 0 |
| Lumea, Inc. | 1 | 0 |
| Pathpresenter Corporation | 1 | 0 |
| Proscia, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 5, 2026 | K261380 | Concentriq AP-Dx Proscia, Inc. | QKQ |
| Dec 9, 2025 | K243449 | INFINITT DPS Infinitt Healthcare Co., Ltd., KR | QKQ |
| Nov 25, 2025 | K252762 | HALO AP Dx Indica Labs, LLC | QKQ |
| Jun 26, 2025 | K243391 | AISight Dx PathAI, Inc. | QKQ |
| Jun 20, 2025 | K250968 | PathPresenter Clinical Viewer Pathpresenter Corporation | QKQ |
| May 14, 2025 | K250414 | CaloPix Tribun Health, FR | QKQ |
| Mar 14, 2025 | K242244 | Viewer+ Lumea, Inc. | QKQ |
| Jan 9, 2025 | K241273 | FullFocus Paige.Ai, Inc. | QKQ |
| Oct 28, 2024 | K240303 | MetaLite DX Digital Pathology Software Jellox Biotech, Inc., TW | QKQ |
| May 30, 2024 | K233126 | aetherSlide Aetherai Co., Ltd., TW | QKQ |
| Aug 11, 2022 | K212361 | Novo PathAI, Inc. | QKQ |
| Mar 1, 2022 | K210811 | Dynamyx Digital Pathology Software Inspirata, Inc. | QKQ |
| Jul 15, 2020 | K201005 | FullFocus Paige.Ai, Inc. | QKQ |
| Mar 31, 2020 | K193054 | Sectra Digital Pathology Module Sectra AB, SE | QKQ |
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