PSY
- Product code
- PSY
- Device name
- Whole Slide Imaging System
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.3700
- Medical specialty
- Pathology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 16
- Summaries archived here
- 15 (direct download)
- 510(k) clearances (all years, FDA)
- 23 (all years; only the last 3 years are listed here)
FDA classification definition
The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear).
510(k) clearances, last 3 years (16)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253554 | 2026-08-07 | Leica Biosystems Imaging, Inc. | Aperio GT 450 DX; Aperio GT 180 DX | |
| K260964 | 2026-07-22 | Hamamatsu Photonics K.K. | NanoZoomer S540MD Slide Scanner System | |
| K251952 | 2026-07-17 | Virasoft Corporation | Virasight | |
| K253606 | 2026-07-15 | Hamamatsu Photonics K.K. | NanoZoomer S20MD Slide scanner system; NanoZoomer S3… | |
| K243871 | 2025-03-06 | Philips Medical Systems Nederland B.V. | Philips IntelliSite Pathology Solution 5.1 | |
| K241717 | 2025-02-28 | Shandon Diagnostics Limited | E1000 Dx Digital Pathology Solution | |
| K242783 | 2024-12-17 | Ventana Medical Systems, Inc. | Roche Digital Pathology Dx | |
| K242848 | 2024-12-10 | Philips Medical Systems Nederland B.V. | Philips IntelliSite Pathology Solution 5.1 | |
| K241871 | 2024-12-02 | Philips Medical Systems Nederland B.V. | Philips IntelliSite Pathology Solution | |
| K233204 | 2024-06-24 | Philips Medical Systems Nederland B.V. | Philips IntelliSite Pathology Solution 5.1 | |
| K232879 | 2024-06-14 | Ventana Medical Systems, Inc. | Roche Digital Pathology Dx (VENTANA DP 200) | |
| K232833 | 2024-05-07 | Indica Labs, Inc. | HALO AP Dx | FDA |
| K232208 | 2024-04-16 | Sectra AB | Sectra Digital Pathology Module (Version 3.3) | |
| K232202 | 2024-04-16 | Leica Biosystems Imaging, Inc. | Aperio GT 450 DX | |
| K230839 | 2024-02-08 | Proscia, Inc. | Concentriq Dx | |
| K233027 | 2023-12-22 | Hamamatsu Photonics K.K. | NanoZoomer S360MD Slide scanner system |
Official FDA classification page: PSY
Classification and pathway per current FDA publications. Data from openFDA (CC0).