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FDA-cleared K242362

Lightning Viewer

Nexsys Electronics Inc. dba Medweb

Authorized purpose: Lightning Viewer is software for diagnostic and clinical review of general-radiology and other healthcare imaging applications. The FDA indication describes review and navigation of diagnostic images with tools for visualization, and use with appropriate displays by trained healthcare professionals.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region diagnostic radiological images
Decision
2024-12-20