# QJU: Image Acquisition And/Or Optimization Guided By Artificial Intelligence

- Device class: 2; regulation: 21 CFR 892.2100; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 212 days (middle half 177–234)
- 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)
- 2020: 3
- 2023: 1
- 2025: 3
- 2026: 3

## Most-cited predicates
- DEN190040: Caption Guidance (2020), cited by 4
- K200755: Caption Guidance (2020), cited by 1
- K242807: HeartFocus (V.1.1.1) (2025), cited by 1
- K201992: Caption Guidance (2020), cited by 1

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