QUANTRA
HOLOGIC, INC.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.
Intended Use
Quantra is a software application intended for use with Hologic digital mammography systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra provides these numerical values for each breast to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid.
Technology
Quantra is a software application that processes digital mammography images. The device does not contact the patient nor controls any life-sustaining devices. It runs on Hologic Cenova DICOM server and extracts breast volume data from FFDM images.
Performance
The software's performance was tested according to Hologic's SOPs and testing procedures to demonstrate adequate performance. Risk management included hazard analysis with identified potential hazards controlled via software development, verification, and validation testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/28/2008
15 days - 2
FDA Approval
9/12/2008
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