FDA Radiology AI Devices
Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.
510k9/12/2008
QUANTRA is software designed for use with digital mammography systems to estimate volumetric breast density. It calculates the ratio of fibroglandular tissue to total breast volume from mammography images, providing quantitative data to assist radiologists in assessing breast tissue composition. The software acts as an adjunct tool and is not intended as a diagnostic or interpretive aid, helping clinicians better understand breast density which is important for patient care.
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