# K182213: QT Ultrasound Breast Scanner - 1

- Pathway: 510(k) (Special)
- Applicant: Qt Ultrasound, LLC
- Decided: Sep 14, 2018 after 30 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 143 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162372: QT Ultrasound Breast Scanner-1, Qt Ultrasound, LLC (2017) Summary page 5.

## Most influential descendants
- K190646: QT Scanner 2000 Model A (2019), 2 descendants of its own
- K220933: QT Scanner 2000 Model A (2022), 1 descendant of its own
- K253898: QT Scanner 2000 Model A (2026), 0 descendants of its own

## Indications for use
The QT Ultrasound Breast Scanner - 1 is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient's breast. The device is not intended to be used as a replacement for screening mammography.

Source page: https://510kreport.com/device/K182213
Methodology: https://510kreport.com/methodology