Lightning Viewer
Nexsys Electronics Inc. dba MedwebLightning Viewer is a web-based medical image viewing software that allows healthcare professionals to review, manipulate, and annotate diagnostic images from various modalities. It supports major desktop browsers, offers advanced visualization tools like 3D MPR and MIP, and integrates with PACS systems to facilitate efficient radiology workflows and aid clinicians in making diagnostic decisions.
Intended Use
Software for diagnostic and clinical review intended for use in General Radiology and other healthcare imaging applications, to review and navigate diagnostic images and aid in visualizing a region of interest.
Technology
Web-based DICOM medical image viewer with tools for image manipulation, measurement, 3D visualization (MPR, MIP, VR), annotation display including from AI/CAD software, supporting multiple modalities and desktop browsers, integrating with PACS.
Performance
Software verification and validation testing showed design requirements met; phantom study demonstrated measurement accuracy; no clinical data needed as device is substantially equivalent to predicate; non-clinical and software testing support safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/9/2024
4 months - 2
FDA Approval
12/20/2024
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