# QTZ: Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

- Device class: 2; regulation: 21 CFR 892.2050; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 249 days (middle half 107–309)
- 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)
- 2022: 1
- 2023: 3
- 2024: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K220256: MIM-Ablation (2022), cited by 2
- K240773: VisAble.IO (2024), cited by 1
- K240796: myAblation Guide (VB80A) (2024), cited by 1
- K223639: VisAble.IO (2023), cited by 1

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