QKQ
15 FDA 510(k) clearances · Product code
238 daysmedian time to decision
377 days90th percentile
15clearances measured
FDA profile
- Official device name
- Digital Pathology Image Viewing And Management Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.3700
- Medical specialty
- Pathology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Aperio iQC DX Software (K253561) | Leica Biosystems Imaging, Inc. | 2026-08-07 |
| Concentriq AP-Dx (K261380) | Proscia, Inc. | 2026-08-05 |
| INFINITT DPS (K243449) | Infinitt Healthcare Co., Ltd. | 2025-12-09 |
| HALO AP Dx (K252762) | Indica Labs, LLC | 2025-11-25 |
| AISight Dx (K243391) | PathAI, Inc. | 2025-06-26 |
| PathPresenter Clinical Viewer (K250968) | Pathpresenter Corporation | 2025-06-20 |
| CaloPix (K250414) | Tribun Health | 2025-05-14 |
| Viewer+ (K242244) | Lumea, Inc. | 2025-03-14 |
| FullFocus (K241273) | Paige.Ai, Inc. | 2025-01-09 |
| MetaLite DX Digital Pathology Software (K240303) | Jellox Biotech, Inc. | 2024-10-28 |
| aetherSlide (K233126) | Aetherai Co., Ltd. | 2024-05-30 |
| Novo (K212361) | PathAI, Inc. | 2022-08-11 |
| Dynamyx Digital Pathology Software (K210811) | Inspirata, Inc. | 2022-03-01 |
| FullFocus (K201005) | Paige.Ai, Inc. | 2020-07-15 |
| Sectra Digital Pathology Module (K193054) | Sectra AB | 2020-03-31 |
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Every clearance here is in the API, with alerts when new ones post.