QT Ultrasound Breast Scanner-1

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K162372 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• QT Scanner 2000 Model A

  Class II

  FDA 510(k) K190646 Active Cleared 18 Oct 2019

• QT Ultrasound Breast Scanner - 1

  Class II

  FDA 510(k) K182213 Active Cleared 14 Sep 2018

• What is the QT Ultrasound Breast Scanner-1 used for?

  The QT Ultrasound Breast Scanner-1 is an ultrasonic imaging system designed to provide reflection-mode and transmission-mode images of a patient's breast tissue. It combines both imaging modes to generate complementary information for assessing breast health, and is intended for use in radiology settings as a non-invasive breast imaging tool.

• How is the QT Ultrasound Breast Scanner-1 supplied and authorized?

  The device is supplied by Qt Ultrasound, LLC and was cleared through the FDA 510(k) process under K number K162372 with product code IYO. Its authorization is based on substantial equivalence to a predicate device, as indicated by the decision code SESE and decision description 'Substantially Equivalent'.

• What type of imaging does the QT Ultrasound Breast Scanner-1 perform?

  The QT Ultrasound Breast Scanner-1 performs both reflection-mode and transmission-mode ultrasound imaging. This dual-mode capability allows it to generate complementary information about breast tissue, enhancing the assessment of breast health beyond what either mode alone could provide.