Whole Slide Imaging System
Regulation 864.3700
4510(k)s in 12 months (23 all time)
1recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PSY
| Company | 510(k)s | Recalls |
|---|---|---|
| Philips Medical Systems Nederland B.V. | 7 | 0 |
| Hamamatsu Photonics K.K. | 4 | 0 |
| Leica Biosystems Imaging, Inc. | 3 | 0 |
| Ventana Medical Systems, Inc. | 2 | 1 |
| Barco N.V. | 1 | 0 |
| Hamamatsu Corporation | 0 | 1 |
| Indica Labs, Inc. | 1 | 0 |
| Philips Electronics Nederland B.V. | 1 | 0 |
| Proscia, Inc. | 1 | 0 |
| Sectra AB | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Ventana Medical Systems, Inc. navify Digital Pathology (on-prem) v2.5, Material Number 10092343001
navify Digital Pathology (Cloud) v2.5. Material Number 09453733001
UDI-DI Code: 761333602095AQ
In the United States, navify Dig Open, Classified |
PSY | K232879 K242783 |
| Aug 1, 2023 | Hamamatsu Corporation NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing f Open, Classified |
PSY | K213883 |
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