Data / Medical devices / Digital Pathology Image Viewing And Management Software
Digital Pathology Image Viewing And Management Software (QKQ): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Digital Pathology Image Viewing And Management Software (product code QKQ, Class 2, 21 CFR 864.3700). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on August 5, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QKQ
- Device class
- 2
- Regulation
- 864.3700
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| South Korea | 1 |
| Taiwan | 1 |
| Sweden | 1 |
| France | 1 |
| United Kingdom | 1 |
Makers of Digital Pathology Image Viewing And Management Software
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Paige.ai, Inc | New York, NY, United States | Manufacturer | 2 | January 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Americas Corporation | Lexington, MA, United States | Manufacturer | 1 | March 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Indica Labs LLC | Albuquerque, NM, United States | Manufacturer | 1 | November 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Infinitt Healthcare Co., Ltd. | Seoul, South Korea | Manufacturer | 1 | December 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Jellox Biotech Inc. | Hsinchu County Hsinchu(County), Taiwan | Manufacturer | 1 | October 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Leica Biosystems Imaging, Inc. | Vista, CA, United States | Manufacturer for export, Repackager or relabeler | 1 | November 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Pathai | Boston, MA, United States | Manufacturer | 1 | June 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Pathpresenter Corp | Montville, NJ, United States | Complaint file establishment, Manufacturer | 1 | June 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sectra AB | LINKOPING Ostergotland, Sweden | Manufacturer | 1 | March 31, 2020 | 0 | 0 | 0 | api.fda.gov |
| Tribun Health | PARIS Ile-de-France, France | Manufacturer | 1 | May 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Proscia, Inc. | Philadelphia, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandon Diagnostics Limited | RUNCORN Cheshire East, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.