Volpara Imaging Software
Volpara Health Technologies LimitedVolpara Imaging Software is a tool designed to analyze raw digital mammography and tomosynthesis images to calculate volumetric breast density. It provides quantitative measurements and density maps to assist healthcare professionals in evaluating breast tissue composition. The software operates on a Windows server outside the patient environment and supports clinical decision-making by providing adjunctive information on breast density, aiding in breast cancer screening assessments.
Intended Use
VolparaDensity is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. It calculates and quantifies a density map and determines volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. It provides numerical values along with a BI-RADS breast density 4th or 5th Edition category to aid health care professionals in assessing breast tissue composition. It is not an interpretive or diagnostic aid and should be used only as adjunctive information when the final assessment is made by a qualified interpreting physician.
Technology
Volpara Imaging Software generates and validates density maps representing thickness of fibroglandular tissue per pixel from raw digital mammograms and tomosynthesis projections. It computes quantitative statistics including volume of fibroglandular tissue, breast volume, volumetric breast density, thickness measures, and focal density. The software outputs DICOM format density maps and numeric data. It runs on Windows servers outside the patient environment and does not control other devices.
Performance
The software has been verified and validated following design control processes, relevant software guidance documents, and ISO standards (ISO 14971, ISO 62304). Testing included unit, system-level, and integration tests, with repeated validation for backward compatibility. Risk analysis and risk management were incorporated. User manuals and labeling include necessary safety instructions and warnings.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/24/2018
28 days - 2
FDA Approval
9/21/2018
Other devices from Volpara Health Technologies Limited
- Volpara Imaging Software2021 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.