# OAS: X-Ray, Tomography, Computed, Dental

- Device class: 2; regulation: 21 CFR 892.1750; FDA's rule: 510(k) required
- FDA decisions: 136
- 510(k) review time 2021–2025: median 113 days (middle half 51–176)
- Recalls: 4 (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: 11
- 2019: 7
- 2020: 9
- 2021: 11
- 2022: 6
- 2023: 12
- 2024: 4
- 2025: 9
- 2026: 9

## Most-cited predicates
- K003787: Newtom QR-DVT 9000 (2001), cited by 6
- K123381: Hyperion X9 (2013), cited by 4
- K160140: DENTRIa    series (2016), cited by 4
- K082350: PAX-500 (2008), cited by 4
- K150217: Orthophos SL (2015), cited by 4
- K213226: RCT700 (2021), cited by 4
- K103659: CS 9300, CS 9300C (2011), cited by 4
- K133544: OP300 (2014), cited by 4
- K123070: Galileos Family (2013), cited by 3
- K170066: Green16/Green18 (Model: PHT-65LHS) (2017), cited by 3

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