# Qt Ultrasound, LLC

- Location (FDA's records): Novato, CA
- FDA decisions: 3 (2017–2019): 3 510(k) clearances
- Product codes: IYO (3)
- 510(k) review time since 2016: median 219 days, against 59 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Delphinus Medical Technologies: 1 (https://510kreport.com/company/delphinus-medical-technologies)

## Firms that cite its devices most
- Qt Imaging, Inc.: 1 (https://510kreport.com/company/qt-imaging)

## Its most-cited devices
- K190646: QT Scanner 2000 Model A (2019), cited by 1
- K182213: QT Ultrasound Breast Scanner - 1 (2018), cited by 1
- K162372: QT Ultrasound Breast Scanner-1 (2017), cited by 1

## Recent decisions
- K190646: QT Scanner 2000 Model A (Oct 18, 2019)
- K182213: QT Ultrasound Breast Scanner - 1 (Sep 14, 2018)
- K162372: QT Ultrasound Breast Scanner-1 (Jun 6, 2017)

Source page: https://510kreport.com/company/qt-ultrasound