# PSY: Whole Slide Imaging System

- Device class: 2; regulation: 21 CFR 864.3700; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 259 days (middle half 121–268)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 2
- 2019: 2
- 2021: 2
- 2022: 1
- 2023: 1
- 2024: 9
- 2025: 2
- 2026: 4

## Most-cited predicates
- DEN160056: Philips IntelliSite Pathology Solution (2017), cited by 9
- K232202: Aperio GT 450 DX (2024), cited by 9
- K233027: NanoZoomer S360MD Slide scanner system (2023), cited by 7
- K213883: NanoZoomer S360MD Slide scanner system (2022), cited by 6
- K190332: Aperio AT2 DX System (2019), cited by 4
- K192259: Philips IntelliSite Pathology Solution (2019), cited by 2
- K203845: Philips IntelliSite Pathology Solution (2021), cited by 2
- K172174: Philips IntelliSite Pathology Solution (2017), cited by 1
- K230839: Concentriq Dx (2024), cited by 1
- K232879: Roche Digital Pathology Dx (VENTANA DP 200) (2024), cited by 1

Source page: https://510kreport.com/product-code/PSY
Data by year (CSV): https://510kreport.com/product-code/PSY.csv