510(k) · Cleared
ClearedaiCockpit AI Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fovia, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 26, 2025 as substantially equivalent to K222476 (Ramsoft, Inc., 2022) after a 271-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- Feb 26, 2025
- Review
- 271 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 deviceK241546 aiCockpit AI ViewerFovia, Inc. · 2025
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 deviceK241546 aiCockpit AI ViewerFovia, Inc. · 2025
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) | K241546 | aiCockpit AI Viewer | Fovia, Inc. | 2025 | — |
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 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K222476 Ramsoft OmegaAl Image Viewer 7LLZ I Device Descript… | 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 31 years and passes through 8 companies; a new generation was cleared every 2.3 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. 2025, 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?
Al Viewer is software for clinical review intended for use in General Radiology and other healthcare imaging applications.
Al Viewer is intended to be used with off the shelf computing devices. Al Viewer supports major desktop browsers such as Microsoft Edge, Chrome, Safari.
Al Viewer can display annotations and measurements as an overlay on images from DICOM objects, and from Al software. The viewer can perform 3D Multi-Planar Reformatting (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). Al Viewer is purposed to aid in reviewing findings through its ability to display clinical documents and reports side by side with the images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241546: aiCockpit AI Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241546
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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