# EHD: Unit, X-Ray, Extraoral With Timer

- Device class: 2; regulation: 21 CFR 872.1800; FDA's rule: 510(k) required
- FDA decisions: 191
- 510(k) review time 2021–2025: median 91 days (middle half 56–145)
- Recalls: 10 (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: 4
- 2018: 5
- 2019: 4
- 2020: 2
- 2021: 1
- 2022: 8
- 2023: 8
- 2024: 7
- 2025: 1
- 2026: 6

## Most-cited predicates
- K173319: KaVo NOMAD Pro 2 Handheld X-ray System (2017), cited by 8
- K063121: Portable X-Ray System, Model Port-X II (2007), cited by 7
- K132041: Rextar X (2013), cited by 6
- K051795: Nomad Dental X-Ray System (2005), cited by 5
- K043092: Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015 (2004), cited by 5
- K973642: Orthopantomograph OP100 and Orthoceph OC100 (1997), cited by 4
- K972312: Siemens Orthophos DS/DS Ceph (1997), cited by 4
- K992610: Gendex 765DC, Model 110-0154 (1999), cited by 4
- K033073: Orthophos XG DS/Ceph (2003), cited by 3
- K090749: Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191 (2009), cited by 3

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