ClearView cCAD
ClearView Diagnostics Inc.ClearView cCAD is an AI-powered software tool that helps physicians analyze breast ultrasound images by automatically classifying lesion shape and orientation characteristics. It supports better screening and diagnosis by generating reports compliant with ACR BI-RADS standards, aiding radiologists in their assessment without replacing primary diagnostic interpretation.
Intended Use
Software application designed to assist skilled physicians in analyzing breast ultrasound images and automatically classifies shape and orientation characteristics of user-selected regions of interest (ROIs).
Technology
Software uses multivariate pattern recognition methods to perform characterization and classification of breast ultrasound images. Runs on Windows platforms as a web service accepting DICOM images, allowing user selection of regions of interest for analysis and generating DICOM compatible reporting.
Performance
Bench testing comparing ClearView cCAD to readings by MQSA certified radiologists showed overall accuracy within 95% confidence interval of expert performance, confirming equivalency in discerning BI-RADS shape and orientation characteristics on over 1200 cases.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/18/2016
5 months - 2
FDA Approval
12/28/2016
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