# MUH: System, X-Ray, Extraoral Source, Digital

- Device class: 2; regulation: 21 CFR 872.1800; FDA's rule: 510(k) required
- FDA decisions: 207
- 510(k) review time 2021–2025: median 64 days (middle half 47–124)
- Recalls: 6 (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: 9
- 2018: 3
- 2019: 5
- 2020: 5
- 2021: 10
- 2022: 7
- 2023: 11
- 2024: 4
- 2025: 3
- 2026: 2

## Most-cited predicates
- K072134: Schick Computed Oral Radiology System (2007), cited by 12
- K090458: Dexis Sensor (2009), cited by 7
- K151926: QuickRay HD Intraoral Sensor (2015), cited by 7
- K060328: Planmeca Promax 3D (2006), cited by 7
- K060178: Vix Win Pro (2006), cited by 6
- K050693: Accent (2005), cited by 5
- K090526: Medical Image Processing Unit, Model Ezsensor (2009), cited by 5
- K041050: Digora Optime (or Digora Ontime) (2004), cited by 4
- K001439: Orthoceph OC100 D (2000), cited by 4
- K061284: I-Cat Scanner (2006), cited by 4

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