QTI’s Breast Acoustic CT™ scanner with QTViewer® viewer software is the only 3D imaging device to receive U.S. Food and Drug Administration (FDA) clearance for use as a transmission and reflection ultrasonic imaging system of a patient’s breast.
FDA Clearances
The FDA’s 510(k) clearance as a supplementary screening device for breast imaging means that QTI’s scanner and software were reviewed and found to be substantially equivalent to a legally marketed device and safe for breast imaging. This represents the same FDA clearance as breast MRI and other breast imaging modalities.
Unlike MRI, the FDA has also 510(k) cleared QTI’s Breast Acoustic CT™ scanner for quantitatively assessing breast fibroglandular volume and breast density — the first ultrasound-based device to receive such clearance.
In 2018, the FDA designated QTI’s Breast Acoustic CT™ scanner as a Breakthrough Device that meets an unmet medical need for screening women at high risk of breast cancer — providing a fast track for QTI to receive unique Current Procedural Terminology (CPT) codes and future clearances.
Technical Capabilities
- Detection resolution of ~600 microns in reflection compared to 800 microns1 for MRI (depends on field strength, homogeneity etc)
- Contrast to noise ratio of 23:1 at 100 microns ( in reflection; can detect small calcifications)
- Contrast to noise ratio of 15:1 (at resolution in transmission
– speed of sound) - Speckle-free because of 360º compounding and refraction correction for reflection image
- Volumetric data acquisition (3D), not stacked 2D slices
- Volumetric reproducibility 0.2% for fibro glandular volume
- Volumetric accuracy better than 3% extrapolated from
linear accuracy ~1% ( vertical < 2%)
- Y. Gao and S. L. Heller, “Abbreviated and Ultrafast Breast MRI in Clinical Practice,” RadioGraphics, vol. 40, pp. 1507-1527, 2020