FDA Product Code
FDA Product Code PSY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Pathology
- 21 CFR Citation
- 864.3700
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253554 | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | 2026-08-07 | Traditional | PDF ↗ |
| K260964 | NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. | 2026-07-22 | Abbreviated | PDF ↗ |
| K251952 | Virasight | Virasoft Corporation | 2026-07-17 | Traditional | PDF ↗ |
| K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2026-07-15 | Abbreviated | PDF ↗ |
| K243871 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2025-03-06 | Traditional | PDF ↗ |
| K241717 | E1000 Dx Digital Pathology Solution | Shandon Diagnostics Limited | 2025-02-28 | Traditional | PDF ↗ |
| K242783 | Roche Digital Pathology Dx | Ventana Medical Systems, Inc. | 2024-12-17 | Special | PDF ↗ |
| K242848 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2024-12-10 | Traditional | PDF ↗ |
| K241871 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2024-12-02 | Traditional | PDF ↗ |
| K233204 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2024-06-24 | Traditional | PDF ↗ |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | Ventana Medical Systems, Inc. | 2024-06-14 | Traditional | PDF ↗ |
| K232833 | HALO AP Dx | Indica Labs, Inc. | 2024-05-07 | Traditional | PDF ↗ |
| K232208 | Sectra Digital Pathology Module (Version 3.3) | Sectra AB | 2024-04-16 | Traditional | PDF ↗ |
| K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | 2024-04-16 | Traditional | PDF ↗ |
| K230839 | Concentriq Dx | Proscia, Inc. | 2024-02-08 | Traditional | PDF ↗ |
| K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2023-12-22 | Abbreviated | PDF ↗ |
| K213883 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2022-09-27 | Traditional | PDF ↗ |
| K203845 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2021-09-17 | Abbreviated | PDF ↗ |
| K203364 | MDPC-8127 | Barco N.V. | 2021-04-15 | Traditional | PDF ↗ |
| K192259 | Philips IntelliSite Pathology Solution | Philips Electronics Nederland B.V. | 2019-09-20 | Special | PDF ↗ |
| K190332 | Aperio AT2 DX System | Leica Biosystems Imaging, Inc. | 2019-05-20 | Traditional | PDF ↗ |
| K172174 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017-10-04 | Abbreviated | PDF ↗ |
| DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017-04-12 | Direct | — |
Product code PSY · Class II · Pathology. Data: openFDA.