# OUO: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

- Device class: 2; regulation: 21 CFR 892.1200; FDA's rule: 510(k) required
- FDA decisions: 15
- 510(k) review time 2021–2025: median 84 days (middle half 71–116)
- 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)
- 2011: 2
- 2013: 1
- 2014: 1
- 2017: 3
- 2019: 2
- 2020: 1
- 2022: 2
- 2024: 1
- 2026: 2

## Most-cited predicates
- K163234: Biograph mMR with syngo MR E11P system software (2017), cited by 4
- K133226: Biograph MMR (2013), cited by 2
- K142098: Signa Pet/MR (2014), cited by 2
- K103429: Biograph MMR (2011), cited by 1
- K200213: Biograph mMR with syngo MR E11P-AP01 system software (2020), cited by 1
- K163619: Signa Pet/MR (2017), cited by 1
- K192672: uPMR 790 (2019), cited by 1
- K183014: uPMR 790 (2019), cited by 1
- K222540: uPMR 790 (2022), cited by 1

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