View

View is a cloud-native software application that displays, processes, and analyzes medical image data and clinical reports to aid diagnosis for healthcare professionals. It provides measurement tools, 2D/3D visualization, and advanced image analysis in a single interface, with specialized support for breast imaging including mammography.

View employs the same fundamental scientific technology as its predicate device (Universal Viewer). Key differences include cloud-only deployment versus on-premises/cloud options, addition of segmentation tools (Smart Brush and Threshold Brush), support for Average Rendering, and FHIRcast API integration instead of proprietary API. The Smart Reading Protocol machine learning algorithm is directly ported from the predicate with no changes to core functionality.

NEMA PS 3.1-3.20 2024e Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard; 21 CFR 820 Quality System Regulations; ISO 13485.

View demonstrates substantial equivalence through identical fundamental technology to its predicate (Universal Viewer K211312), equivalent core features including native breast imaging support and AI workflow capabilities, successful design verification and validation testing, and all new features (segmentation tools, Average Rendering, FHIRcast API) already present in reference devices. The device was developed under quality system requirements with appropriate risk management and software documentation.