Affinity
Hermes Medical Solutions ABAffinity is a medical imaging software tool that helps clinicians view, process, and analyze nuclear medicine and radiology images. By using AI-powered (deep learning) segmentation, it assists with visualizing organs, quantifying image data, and supporting clinical decisions, particularly in cancer management and surgical planning.
Intended Use
Affinity displays, processes and analyzes nuclear medicine and radiology imaging data for investigation of physiological or pathological states. It provides quantitative analysis to inform clinical management but is not intended to replace visual assessment by users.
Technology
Affinity is a multi-modality image viewing software with advanced 2D/3D visualization, deep learning-based organ segmentation, image fusion, registration, and quantitative analysis tools. The semi-automatic segmentation algorithm can identify and segment organs across CT and functional images, facilitating clinical workflows including surgical planning.
Performance
Software verification and validation testing, including non-clinical performance assessments and algorithm validations against expert-drawn ground truth, demonstrated the device meets performance requirements and performs as intended. The organ segmentation algorithm was benchmarked using standard difference analysis.
Predicate Devices
No predicate devices specified
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