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QTI Breast Acoustic CT™ Scanner
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...
What is QTI Breast Acoustic CT™ Scanner?
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 quantitatively assessing breast fibroglandular volume and breast density; designated FDA Breakthrough Device in 2018.
Product typeDiagnostics & Imaging
Pricing ·
Deployment
APINot available
What teams use QTI Breast Acoustic CT™ Scanner for
radiation-free breast imaging
breast density assessment
supplementary breast cancer screening
screening in low-resource or mobile settings
imaging for patients with MRI contraindications
imaging for women with implants
accurate diagnosis in dense breasts
reduction of overdiagnosis and unnecessary follow-ups
elimination of operator dependency
volumetric accuracy and growth monitoring
Integrations and access
Platforms, integrations, and language support vary by plan and region. Confirm final requirements with the vendor.
Platforms
IntegrationsAPI and webhooks
Languages
Support
What reviewers say
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Enterprise readiness
Compliance claims are normalized from current vendor documentation and independently reviewed by SOTA2.
FIPS 140-3
FDA 510(k) clearance — quantitative assessment of breast fibroglandular volume and density
FDA Breakthrough Device designation (2018)
FDA routine inspection with zero Form 483 observations
California Shine the Light law (Cal. Civ. Code § 1798.83)
Data security safeguards (implemented to protect personal information from loss, misuse, unauthorized access, disclosure, alteration, and destruction)
Data retention:
Benchmarks and comparisons
Independent benchmarksStructured task results are being verified.
Side-by-side comparisonsComparison workspaces will be available in a later release.
