# K253898: QT Scanner 2000 Model A

- Pathway: 510(k) (Special)
- Applicant: QT Imaging Holdings, Inc.
- Decided: Mar 4, 2026 after 89 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: 22 generations back to K935595 (1995). 146 ancestors in all.
No later device cites it as a predicate yet.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220933: QT Scanner 2000 Model A, Qt Imaging, Inc. (2022) Summary page 6.

## Indications for use
The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient's breast. The QT Scanner 2000 Model A software also calculates the breast fibroglandular tissue volume (FGV) value and the ratio of FGV to total breast volume (TBV) value as determined from reflection-mode and transmission-mode ultrasound images of a patient's breast. The device is not intended to be used as a replacement for screening mammography. The QT Scanner 2000 Model A is indicated for use by trained healthcare professionals in environments where healthcare is provided to enable breast imaging in adult patients.

Source page: https://510kreport.com/device/K253898
Methodology: https://510kreport.com/methodology