# QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

- Device class: 2; regulation: 21 CFR 892.2090; FDA's rule: 510(k) required
- FDA decisions: 40
- 510(k) review time 2021–2025: median 168 days (middle half 116–205)
- 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: 2
- 2019: 2
- 2020: 3
- 2021: 5
- 2022: 4
- 2023: 2
- 2024: 7
- 2025: 5
- 2026: 10

## Most-cited predicates
- K181704: Transpara (2018), cited by 6
- K210670: BU-CAD (2021), cited by 3
- K211678: Lunit INSIGHT MMG (2021), cited by 2
- K241831: Transpara (2.1.0) (2024), cited by 2
- K212783: ProstatID (2022), cited by 2
- K182373: PowerLook Tomo Detection V2 Software (2018), cited by 2
- K221347: Transpara 1.7.2 (2022), cited by 2
- K221449: Genius AI Detection 2.0 (2022), cited by 2
- K193229: Transpara (2020), cited by 2
- K242652: Lunit INSIGHT DBT v1.1 (2024), cited by 2

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