PSY — Whole Slide Imaging System Class II
FDA product code PSY covers "Whole Slide Imaging System", a Class II medical device regulated under 21 CFR 864.3700. Submissions are reviewed by the Pathology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PSY
- Device Class
- Class II
- Regulation Number
- 864.3700
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251952 | virasoft corporation | Virasight | July 17, 2026 |
| K253606 | hamamatsu photonics k.k | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | July 15, 2026 |
| K243871 | philips medical systems nederland | Philips IntelliSite Pathology Solution 5.1 | March 6, 2025 |
| K241717 | shandon diagnostics limited | E1000 Dx Digital Pathology Solution | February 28, 2025 |
| K242783 | ventana medical systems | Roche Digital Pathology Dx | December 17, 2024 |
| K242848 | philips medical systems nederland | Philips IntelliSite Pathology Solution 5.1 | December 10, 2024 |
| K241871 | philips medical systems nederland | Philips IntelliSite Pathology Solution | December 2, 2024 |
| K233204 | philips medical systems nederland | Philips IntelliSite Pathology Solution 5.1 | June 24, 2024 |
| K232879 | ventana medical systems | Roche Digital Pathology Dx (VENTANA DP 200) | June 14, 2024 |
| K232833 | indica labs | HALO AP Dx | May 7, 2024 |
| K232208 | sectra | Sectra Digital Pathology Module (Version 3.3) | April 16, 2024 |
| K232202 | leica biosystems imaging | Aperio GT 450 DX | April 16, 2024 |
| K230839 | proscia | Concentriq Dx | February 8, 2024 |
| K233027 | hamamatsu photonics k.k | NanoZoomer S360MD Slide scanner system | December 22, 2023 |
| K213883 | hamamatsu photonics k.k | NanoZoomer S360MD Slide scanner system | September 27, 2022 |
| K203845 | philips medical systems nederland | Philips IntelliSite Pathology Solution | September 17, 2021 |
| K203364 | barco n.v | MDPC-8127 | April 15, 2021 |
| K192259 | philips electronics nederland | Philips IntelliSite Pathology Solution | September 20, 2019 |
| K190332 | leica biosystems imaging | Aperio AT2 DX System | May 20, 2019 |
| K172174 | philips medical systems nederland | Philips IntelliSite Pathology Solution | October 4, 2017 |