QT Scanner 2000 Model A

The QT Scanner 2000 Model A is an automated ultrasound imaging system that scans the entire breast without compression or ionizing radiation, producing reflection-mode and transmission-mode images. The software calculates fibroglandular tissue volume (FGV) and its ratio to total breast volume (TBV). It is intended for use by trained healthcare professionals to enable breast imaging in adult patients and is not a replacement for screening mammography.

The subject device incorporates a software-only modification with the transmission transducer and receiver tilted five degrees to improve incident field alignment compared to the predicate. All other technological characteristics remain identical: same transducer configuration, same acoustic output (Max ISPTA = 1.89 mW/cm²), same imaging modes, same image processing (general and implant processing), and same patient positioning and fluid environment approach.

ISO 10993-1:2009/(R)2013 (biocompatibility), IEC 60601-1:2012 (electrical safety), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-2-37:2015 (acoustic safety), NEMA UD 2-2004 (R2009), IEC 60601-1-6:2013 and IEC 62366:2014 (usability), and IEC 62304:2015 (software lifecycle).

The subject device is substantially equivalent because it has identical indications for use and core imaging capabilities as the predicate (K220933). The software-only modification does not alter acoustic transmit characteristics, patient-contacting materials, electrical construction, or mechanical assemblies. Clinical testing via visual grading analysis demonstrated improved image quality without changing core capabilities, and no clinically significant differences were observed compared to the predicate device.