# NZT: Dosimeter, Ionizing Radiation, Implanted

- Device class: 2; regulation: 21 CFR 892.5050; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 261 days (middle half 261–261)
- Recalls: 5 (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)
- 2008: 2
- 2014: 1
- 2015: 1
- 2017: 1
- 2019: 1
- 2025: 1

## Most-cited predicates
- K141154: Oartrac System (2014), cited by 2
- K162954: OARtrac System with Patient Specific Reusable Universal PSD Sensors (2017), cited by 1
- K083035: Dose Verification System Patient Dosimetry System (2008), cited by 1
- K150719: OARtrac System with Skin Sensors (2015), cited by 1
- K080004: Dose Verification System Patient Dosimetry System (2008), cited by 1

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