# MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

- Device class: 2; regulation: 21 CFR 892.1680; FDA's rule: 510(k) required
- FDA decisions: 424
- 510(k) review time 2021–2025: median 51 days (middle half 27–101)
- Recalls: 133 (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: 31
- 2018: 16
- 2019: 22
- 2020: 19
- 2021: 21
- 2022: 31
- 2023: 10
- 2024: 8
- 2025: 8
- 2026: 3

## Most-cited predicates
- K031447: Canon, Digital Radiography, Model Cxdi-50G (2003), cited by 16
- K982795: Philips Bucky Vision (1998), cited by 11
- K090742: Digital Flat Panel X-Ray Detector, Model LTX240AA01-a (2009), cited by 8
- K080064: Flaatz 750 (2008), cited by 8
- K981556: Canon X-Ray Digital Camera Cxdi-11 (1998), cited by 7
- K090625: Wireless Portable Detector FD-W17 (2009), cited by 7
- K102587: LLX240AB01 (2010), cited by 7
- K142003: FDR D-Evo II Flat Panel Detector System (2014), cited by 6
- K024147: Paxscan 4030 Medical Digital Imaging System (2003), cited by 6
- K201528: Yushan X-Ray Flat Panel Detector with DROC (2020), cited by 6

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