Data / Medical devices / Digital Pathology Image Viewing And Management Software / United States
FDA-registered makers of Digital Pathology Image Viewing And Management Software in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Digital Pathology Image Viewing And Management Software (product code QKQ). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Digital Pathology Image Viewing And Management Software
- Product code
- QKQ
- Country
- United States
Makers of Digital Pathology Image Viewing And Management Software in the United States
| 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 |
| 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 |
| Proscia, Inc. | Philadelphia, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.