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FDA-cleared K161201

ClearRead CT

RIVERAIN TECHNOLOGIES, LLC

Authorized purpose: ClearRead CT is a post-processing adjunct for detecting pulmonary nodules on chest CT in an asymptomatic population; it generates a secondary vessel-suppressed lung CT with CADe marks and region descriptors and must be reviewed with the original CT series.

Modality
CT/CTA
Anatomy
Chest/lungs
Decision
2016-09-09