510(k) · Cleared
ClearedLucion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mevisys Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Feb 11, 2005 as substantially equivalent to K022692 (Mevisys Co., Ltd., 2002) and 1 other predicate after a 35-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Feb 11, 2005
- Review
- 35 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945512 (1995). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 3 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 2 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 1 generation backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- This deviceK050033 LucionMevisys Co., Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK062164 Resolutionmd, Version 1.3Calgary Scientific, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK100236 Stair Systems Pacs & Dicom ViewerStair Systems, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK112008 Touchpacs SuiteTouch Medical Solutions, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −3 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −2 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −1 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| 0 (this device) | K050033 | Lucion | Mevisys Co., Ltd. | 2005 | — |
| +1 | K062164 | Resolutionmd, Version 1.3 | Calgary Scientific, Inc. | 2006 | — |
| +2 | K100236 | Stair Systems Pacs & Dicom Viewer | Stair Systems, Inc. | 2010 | — |
| +3 | K112008 | Touchpacs Suite | Touch Medical Solutions, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K022692 | Voxelplus PacsSummary page 1…evice 1: 21 CFR 807. 92(a) (3) Device Classification Name SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Regulation Number 892.2050 510(k) Number K022692 Device Name VOXELPLUS PACS Mevisys Co.,Ltd. Applicant KAIST-A… | 2002 |
| * | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5Summary page 1…1/2002 Predicate Device 2: Device Classification Name SYSTEM, X-Ray, Tomography Computed Regulation Number 892.1750 510(k) Number K020929 Device Name SmartScore 3.5, 4.0, 4.5… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062164 | Resolutionmd, Version 1.3 | 2006 | 2 |
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 10 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K062164 (Calgary Scientific, Inc., 2006) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K022692.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Lucion TM is a software application for the display and 3D visualization of medical image data derived from various sources (i.e. CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050033 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050033: Lucion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050033
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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