ClearRead CT
RIVERAIN TECHNOLOGIES, LLCClearRead CT is a software application that helps radiologists detect lung nodules in chest CT scans by providing enhanced image processing with vessel suppression and computer-aided marking. This assists radiologists in identifying potential nodules more effectively and efficiently during their review, improving diagnostic accuracy and workflow.
Intended Use
ClearRead CT is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest on an asymptomatic population. The ClearRead CT requires both lungs be in the field of view. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.
Technology
ClearRead CT is a dedicated post-processing application that generates a secondary vessel suppressed Lung CT series with CADe marks and associated region descriptors to assist radiologists in detecting pulmonary nodules.
Performance
Clinical validation was performed with a multi-reader multi-case study showing that ClearRead CT significantly improves detection accuracy (AUC) and reduces interpretation time compared to unaided reading. Developmental testing and risk analysis also demonstrated device safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/28/2016
4 months - 2
FDA Approval
9/9/2016
Other devices from RIVERAIN TECHNOLOGIES, LLC
- ClearRead Xray Pneumothorax2022 • 510K
- CLEARREAD +CONFIRM2012 • 510K
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