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QTI Breast Acoustic CT™ Scanner

Diagnostics and imaging · by QT Imaging Holdings, Inc.

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.

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What it does

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.

  • 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
Category
Diagnostics and imaging
Built for
Healthcare and life sciences
Users
breast imaging facilities, breast cancer screening centers
Public API
Not offered

Not yet disclosed: deployment options, platforms, languages and support channels.

Pricing

Pricing isn't published

QT Imaging Holdings, Inc. doesn't list prices publicly. Ask them for a quote.

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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