# QKB: Radiological Image Processing Software For Radiation Therapy

- Device class: 2; regulation: 21 CFR 892.2050; FDA's rule: 510(k) required
- FDA decisions: 49
- 510(k) review time 2021–2025: median 131 days (middle half 94–193)
- Recalls: 0 (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)
- 2018: 1
- 2020: 4
- 2021: 9
- 2022: 7
- 2023: 7
- 2024: 6
- 2025: 6
- 2026: 9

## Most-cited predicates
- K191928: AccuContour (2020), cited by 10
- K181572: Workflow Box (2018), cited by 6
- K203235: VBrain (2021), cited by 4
- K242745: AI-Rad Companion Organs RT (2025), cited by 2
- K230685: AutoContour Model RADAC V3 (2023), cited by 2
- K221706: AccuContour (2023), cited by 2
- K221305: AI-Rad Companion Organs RT (2022), cited by 2
- K242994: OncoStudio (OS-01) (2025), cited by 1
- K230082: Auto Segmentation (2023), cited by 1
- K202700: ART-Plan (2021), cited by 1

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