# K162372: QT Ultrasound Breast Scanner-1

- Pathway: 510(k) (Traditional)
- Applicant: Qt Ultrasound, LLC
- Decided: Jun 6, 2017 after 286 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: 18 generations back to K935595 (1995). 142 ancestors in all.
4 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)
- K142517: SoftVue, Delphinus Medical Technologies, Inc. (2014) Summary page 5.

## Most influential descendants
- K182213: QT Ultrasound Breast Scanner - 1 (2018), 3 descendants of its own
- 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
Additional Comments: QT Ultrasound Breast Scanner-1 is intended for ultrasonic breast exams

Source page: https://510kreport.com/device/K162372
Methodology: https://510kreport.com/methodology