# QIH: Automated Radiological Image Processing Software

- Device class: 2; regulation: 21 CFR 892.2050; FDA's rule: 510(k) required
- FDA decisions: 338
- 510(k) review time 2021–2025: median 142 days (middle half 92–219)
- Recalls: 1 (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)
- 2019: 2
- 2020: 11
- 2021: 19
- 2022: 25
- 2023: 45
- 2024: 64
- 2025: 94
- 2026: 78

## Most-cited predicates
- K191647: QLAB Advanced Quantification Software (2019), cited by 6
- K213998: cvi42 Auto Imaging Software Application (2022), cited by 6
- K203256: Imbio RV/LV Software (2021), cited by 6
- K220497: CoLumbo (2022), cited by 4
- K210053: LVivo Software Application (2021), cited by 4
- K233925: Relu Creator (2024), cited by 4
- K211222: qER-Quant (2021), cited by 4
- K210791: Us2.v1 (2021), cited by 3
- K213544: Tomtec-Arena (2022), cited by 3
- K221738: NS-HGlio (2022), cited by 3

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