Quantra
HOLOGIC, INC.Quantra is a software tool designed to analyze digital mammographic images and estimate breast tissue composition. It categorizes breast density in a way that aligns with BI-RADS breast composition reporting standards to help radiologists assess breast tissue, aiding consistent reporting for breast cancer screening and diagnosis support, though it is not a diagnostic aid itself.
Intended Use
The Quantra software application is intended for use with mammographic images acquired using digital breast x-ray systems. It segregates breast density into categories, aiding radiologists in reporting consistent BI-RADS breast composition categories.
Technology
The software analyzes mammographic images by evaluating the distribution and texture of fibroglandular tissue to classify breast density according to BI-RADS 5th Edition standards. It produces volumetric and area density scores to aid radiologists, using an improved algorithm for accuracy compared to predicates.
Performance
Non-clinical testing was performed retrospectively with 230 screening-negative mammographic studies with consensus BI-RADS 5th edition assessments. The software version 2.2 showed high accuracy (over 90%) in classifying fatty vs dense breasts compared to radiologist consensus. No animal or clinical studies were conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/22/2016
10 months - 2
FDA Approval
10/20/2017
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