510(k) · Cleared
ClearedLightning Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexsys Electronics Inc. Dba Medweb · LLZ System, Image Processing, Radiological
Cleared on Dec 20, 2024 as substantially equivalent to K222476 (Ramsoft, Inc., 2022) after a 133-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- Dec 20, 2024
- Review
- 133 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K942120 (1994). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 6 generations between
- 3 generations backK131977 Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013 · Recalled
- 2 generations backK141881 RapidresultsRamsoft, Inc. · 2014
- 1 generation backK222476 OmegaAI Image ViewerRamsoft, Inc. · 2022
- This deviceK242362 Lightning ViewerNexsys Electronics Inc. Dba Medweb · 2024
Show all 10 generations
- Root · 10 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 9 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 8 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 7 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 6 generations backK082318 Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- 5 generations backK121387 Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 2012 · Recalled
- 4 generations backK123174 Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · Recalled
- 3 generations backK131977 Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013 · Recalled
- 2 generations backK141881 RapidresultsRamsoft, Inc. · 2014
- 1 generation backK222476 OmegaAI Image ViewerRamsoft, Inc. · 2022
- This deviceK242362 Lightning ViewerNexsys Electronics Inc. Dba Medweb · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −9 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −8 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −7 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −6 | K082318 | Centricity Pacs IW | Ge Healthcare Dynamic Imaging Solutions | 2008 | 7 |
| −5 | K121387 | Centricity Pacs-IW | Ge Healthcare Integrated IT Solutions | 2012 | 1 |
| −4 | K123174 | Centricity Pacs-IW with Universal Viewer | GE Healthcare | 2012 | 10 |
| −3 | K131977 | Centricity Universal Viewer Zero Footprint Client | GE Healthcare | 2013 | 8 |
| −2 | K141881 | Rapidresults | Ramsoft, Inc. | 2014 | — |
| −1 | K222476 | OmegaAI Image Viewer | Ramsoft, Inc. | 2022 | — |
| 0 (this device) | K242362 | Lightning Viewer | Nexsys Electronics Inc. Dba Medweb | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222476 | OmegaAI Image ViewerSummary page 6…Rev C Effective Date: 2024-12-20 Page 2 of 7 Item Description 510(k) Number K222476 Product Code LLZ Regulation Number 892.2050 Regulation Name System, Image Processing, Radiological Regulator… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 26 ancestors have a recall of any class.
- 2 other devices also cite its predicate K222476.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (348 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242362: Lightning Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242362
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026