Careverse CoronaryDoc (Careverse CoronaryDoc)

Careverse CoronaryDoc is a web-based software application that analyzes cardiac CT images to help trained medical professionals identify and measure coronary plaques and stenosis in patients being evaluated for coronary artery disease. The software processes CT data using tools for 2D/3D visualization, measurement, and automated analysis of coronary arteries, providing structured reports to assist physician diagnosis.

The device shares identical technological features with its predicate (Cleerly Labs v2.0): both are Class II medical image management systems using DICOM 3.0 input, accepting CT images, and providing 2D/3D imaging, multiplanar reformatting, segmentation, plaque composition analysis, stenosis grading, volumetric measurements, and coronary reports. Both are web-based interactive tools requiring trained operator use.

ISO 14971:2019 (risk management), ISO 13485:2016 (quality management), IEC 62304:2015 (software lifecycle), ISO/TR 24971:2020 (software application guide), GB/T 25000.51-2016 (software quality), FDA General Principles of Software Validation (2012), and cybersecurity/GMP inspection guidelines.

Careverse CoronaryDoc is substantially equivalent because it has identical intended use, indications for use, and technological characteristics as predicate K202280 (Cleerly Labs v2.0). Performance validation demonstrated the software meets specifications with acceptable segmentation (Dice Coefficient 0.899 vs. threshold 0.842), labeling accuracy (93-98%), and stenosis grading agreement (83-99% across grades). Both devices perform the same post-processing and analysis functions on CCTA images with the same regulatory classification and product code.