Medical device company dedicated to transforming breast health management through radiation-free imaging technology combining Quantitative Transmission (QT) ultrasound, AI, and biomarkers.
Medical device company dedicated to transforming breast health management through radiation-free imaging technology combining Quantitative Transmission (QT) ultrasound, AI, and biomarkers.
3D imaging device FDA-cleared as a transmission and reflection ultrasonic imaging system for the breast; 510(k) cleared as a supplementary screening device and for quantitativel...
Viewer software for use with the QTI Breast Acoustic CT™ scanner, referenced as a first-party product in navigation and product page.
What customers say
“Seeking an Alternative Lizzie Rovsek visits Dr. Leigh Erin Connealy at Center For New Medicine, seeking a true alternative to traditional breast imaging.”
CustomerQT Imaging Holdings, Inc. customer
Security and compliance
As reported by QT Imaging Holdings, Inc.. Ask for audit reports before you buy.
FIPS 140-3Compliant
FDA 510(k) clearance — quantitative assessment of breast fibroglandular volume and densityCompliant
FDA Breakthrough Device designation (2018)Compliant
FDA routine inspection with zero Form 483 observationsCompliant
California Shine the Light law (Cal. Civ. Code § 1798.83)Compliant
Data security safeguards (implemented to protect personal information from loss, misuse, unauthorized access, disclosure, alteration, and destruction)
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QT Imaging Completes First FDA Routine Inspection with No Observations
QT Imaging Holdings, Inc. successfully completed its first routine U.S. Food and Drug Administration (FDA) inspection of its Quality Management System (QMS). The company received zero Form 483 observations, indicating that the inspector found no conditions constituting violations of the Food, Drug and Cosmetic Act and related regulations during the review of the company's operational processes.
MentionedU.S. Food and Drug Administration
Research
QT Imaging Publishes Reproducibility Results for Breast Imaging Biomarkers
QT Imaging reported results from a multi-site study characterizing the repeatability and reproducibility of quantitative biomarkers produced by its Breast Acoustic CT Scanner platform. The study found that Speed of Sound measurements achieved a within-subject coefficient of variation of less than 1%, while volumetric measurements showed variability between 5% and 12%. The research highlights the platform's consistency compared to published benchmarks for breast MRI, supporting its application for longitudinal patient monitoring and quantitative clinical assessment.
