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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2026 | K253554 | Aperio GT 450 DX; Aperio GT 180 DX Leica Biosystems Imaging, Inc. | PSY |
| Jul 22, 2026 | K260964 | NanoZoomer S540MD Slide Scanner System Hamamatsu Photonics K.K., JP | PSY |
| Jul 17, 2026 | K251952 | Virasight Virasoft Corporation | PSY |
| Jul 15, 2026 | K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system Hamamatsu Photonics K.K., JP | PSY |
| Mar 6, 2025 | K243871 | Philips IntelliSite Pathology Solution 5.1 Philips Medical Systems Nederland B.V., NL | PSY |
| Feb 28, 2025 | K241717 | E1000 Dx Digital Pathology Solution Shandon Diagnostics Limited, GB | PSY |
| Dec 17, 2024 | K242783 | Roche Digital Pathology Dx Ventana Medical Systems, Inc. | PSY |
| Dec 10, 2024 | K242848 | Philips IntelliSite Pathology Solution 5.1 Philips Medical Systems Nederland B.V., NL | PSY |
| Dec 2, 2024 | K241871 | Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V., NL | PSY |
| Jun 24, 2024 | K233204 | Philips IntelliSite Pathology Solution 5.1 Philips Medical Systems Nederland B.V., NL | PSY |
| Jun 14, 2024 | K232879 | Roche Digital Pathology Dx (VENTANA DP 200) Ventana Medical Systems, Inc. | PSY |
| May 7, 2024 | K232833 | HALO AP Dx Indica Labs, Inc. | PSY |
| Apr 16, 2024 | K232208 | Sectra Digital Pathology Module (Version 3.3) Sectra AB, SE | PSY |
| Apr 16, 2024 | K232202 | Aperio GT 450 DX Leica Biosystems Imaging, Inc. | PSY |
| Feb 8, 2024 | K230839 | Concentriq Dx Proscia, Inc. | PSY |
| Dec 22, 2023 | K233027 | NanoZoomer S360MD Slide scanner system Hamamatsu Photonics K.K., JP | PSY |
| Sep 27, 2022 | K213883 | NanoZoomer S360MD Slide scanner system Hamamatsu Photonics K.K., JP | PSY |
| Sep 17, 2021 | K203845 | Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V., NL | PSY |
| Apr 15, 2021 | K203364 | MDPC-8127 Barco N.V., BE | PSY |
| Sep 20, 2019 | K192259 | Philips IntelliSite Pathology Solution Philips Electronics Nederland B.V., NL | PSY |
| May 20, 2019 | K190332 | Aperio AT2 DX System Leica Biosystems Imaging, Inc. | PSY |
| Oct 4, 2017 | K172174 | Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V., NL | PSY |
| Apr 12, 2017 | DEN160056 | Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V., NL | PSY |
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