Data / Medical devices / Whole Slide Imaging System
Whole Slide Imaging System (PSY): 12 FDA-registered makers in 8 countries
12 establishments in 8 countries are registered with the FDA to make Whole Slide Imaging System (product code PSY, Class 2, 21 CFR 864.3700). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on August 7, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PSY
- Device class
- 2
- Regulation
- 864.3700
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Netherlands | 1 |
| Japan | 1 |
| Belgium | 1 |
| United Kingdom | 1 |
| Italy | 1 |
| Germany | 1 |
| China | 1 |
Makers of Whole Slide Imaging System
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 |
|---|---|---|---|---|---|---|---|---|
| Philips Medical Systems Nederland B.V. | Best Noord-Brabant, Netherlands | Complaint file establishment, Manufacturer | 5 | March 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hamamatsu Photonics K.K., Systems Division | HAMAMATSU CITY Shizuoka, Japan | Complaint file establishment, Manufacturer | 4 | July 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Leica Biosystems Imaging, Inc. | Vista, CA, United States | Manufacturer, Manufacturer for export | 2 | August 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ventana Medical Systems, Inc. | Tucson, AZ, United States | Specification developer | 2 | December 17, 2024 | 0 | 1 | 0 | api.fda.gov |
| Barco N.V. | KORTRIJK West-Vlaanderen, Belgium | Manufacturer | 1 | April 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Proscia, Inc. | Philadelphia, PA, United States | Manufacturer | 1 | February 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shandon Diagnostics Limited | RUNCORN Cheshire East, United Kingdom | Complaint file establishment, Manufacturer | 1 | February 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Barco S.R.L. | Saronno Varese, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss CMP GMBH | Goettingen Lower Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Americas Corporation | Lexington, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paige.ai, Inc | New York, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 7, 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.