# K242362: Lightning Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Nexsys Electronics Inc. Dba Medweb
- Decided: Dec 20, 2024 after 133 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K942120 (1994). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222476: OmegaAI Image Viewer, Ramsoft, Inc. (2022) Summary page 6.

## Indications for use
Lightning Viewer is software for diagnostic and clinical review intended for use in General Radiology (images from modalities including CR/DR/XT, CT, FL, MR, MG, NM, US/US Echo, PET, VL) and other healthcare imaging applications. Lightning Viewer is intended to be used with off the shelf computing devices. Display monitors used for reading medical images for diagnostic purposes must comply with applicable clinical requirements, regulatory approvals, and with quality control requirements for their use and maintenance. With appropriate display monitors, lighting, image quality, and level of lossy image compression, Lightning Viewer is intended for diagnostic purposes to be used by trained healthcare professionals. Display calibration and lighting conditions should be verified by viewing a test pattern prior to use for diagnostic purposes. Lightning Viewer supports major desktop browsers such as Microsoft Edge, Chrome, Safari, and Windows. Lightning Viewer displays both lossless and lossy compressed images. Each healthcare professional must ensure that they have the necessary environment to ensure the appropriate image quality for their clinical purpose and determine the level of lossy image compression acceptable for their purpose. Lossy image compression should not be used for primary reading in mammography. Lightning Viewer can be utilized for image manipulation by radiology technologists or other healthcare professionals. Lightning Viewer can be used to verify that images captured in a medical imaging system have a diagnostic quality; to correct viewing characteristics of the image such as orientation, rotation, and contrast; as well as to add annotations to mark significant findings or provide guidance for radiologists. Lightning Viewer can store annotations and measurements as DICOM presentation states without changing the original image data. Lightning Viewer can display annotations and measurements as an overlay on images from DICOM objects, and from Computer-Aided Diagnosis (CAD) and Al software. The viewer can perform 3D Multi-Planar Reformatting (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). Lightning Viewer is purposed to aid in reviewing findings through its ability to display clinical documents and reports side by side with the images. This can be used side by side with a reporting tool to create diagnostic reports.

Source page: https://510kreport.com/device/K242362
Methodology: https://510kreport.com/methodology