# PGY: Display, Diagnostic Radiology

- Device class: 2; regulation: 21 CFR 892.2050; FDA's rule: 510(k) required
- FDA decisions: 138
- 510(k) review time 2021–2025: median 58 days (middle half 46–104)
- Recalls: 0 (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: 11
- 2018: 5
- 2019: 11
- 2020: 12
- 2021: 7
- 2022: 10
- 2023: 17
- 2024: 10
- 2025: 3
- 2026: 4

## Most-cited predicates
- K151883: 5MP Monochrome LCD Monitor, RadiForce GX540 (2015), cited by 6
- K153354: 3MP Color LCD Monitor, RadiForce RX350 (2016), cited by 5
- K160326: 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) (2016), cited by 4
- K172738: RadiForce RX560, RX560-AR (2017), cited by 4
- K191137: 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 (2019), cited by 4
- K182591: RadiForce RX360, RX360-AR (2018), cited by 3
- K201777: 31HN713D (2020), cited by 3
- K201211: 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ (2020), cited by 3
- K163335: 6MP Color LCD Monitor, RadiForce RX660, RX660-AR (2016), cited by 3
- K160247: 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR (2016), cited by 3

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