Lightning Viewer

Lightning Viewer is a web-based software application for diagnostic and clinical review of radiological images from multiple modalities (CR/DR/XT, CT, FL, MR, MG, NM, US/US Echo, PET, VL). It allows trained healthcare professionals to view, manipulate, measure, and annotate medical images accessed through standard desktop browsers without requiring client software installation.

Lightning Viewer uses web-based architecture with DICOM, DICOMweb, WADO, REST, and HL7 standards. It provides image manipulation tools (window/level, rotate, flip, pan, zoom), measurement and annotation capabilities including DICOM presentation states, 3D visualization (MPR, MIP, VR), and support for both lossless and lossy compressed images across major browsers (Chrome, Safari, Edge).

Not stated in this summary.

Lightning Viewer is substantially equivalent to the OmegaAI Image Viewer predicate device because both are zero-footprint web-based/server-based DICOM viewers with identical intended diagnostic use and indications for radiological image review. Both devices share the same core functionality including image manipulation, measurement tools, annotation capabilities, 3D visualization, and support for major imaging modalities. While Lightning Viewer is web-based versus the predicate's server-based architecture, and has narrower platform support and fewer specialty tools, these differences do not raise new safety or effectiveness questions. Software verification and validation testing confirmed design requirements were met and non-clinical phantom testing demonstrated accurate measurement calculations equivalent to the predicate.