510(k) · Cleared
ClearedVoxelplus Pacs
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 Oct 11, 2002 as substantially equivalent to K992654 (Voxar Limited, 1999) after a 59-day review. Its family tree reaches back 3 generations to 1996. 1 of the 256 devices in its family, counting itself, has a Class I recall. 252 later devices descend from it.
- Decided
- Oct 11, 2002
- Review
- 59 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954678 (1996). 252 later devices descend from it, 4 citing it directly. 1 of the 256 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 2 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 1 generation backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- This deviceK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- Descendant · cites it directly · 226 of its ownK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- Descendant · 2 generations on · 217 of its ownK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- Descendant · 3 generations on · 195 of its ownK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- Descendant · 4 generations on · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- Descendant · 5 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
Showing 5 of 252 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 252 · See all- K051528Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005 · cites it directly226descendants
- K061696Iqqa-Liver SoftwareEdda Technology, Inc. · 2006 · 2 generations on217descendants
- K071310Syngo CT Oncology Software PackageSiemens AG · 2007 · 3 generations on195descendants
- K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · 4 generations on117descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 5 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −2 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −1 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| 0 (this device) | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| +1 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| +2 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| +3 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| +4 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +5 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 10 | 0 |
| 2013 | 7 | 0 |
| 2014 | 14 | 0 |
| 2015 | 15 | 0 |
| 2016 | 15 | 0 |
| 2017 | 8 | 0 |
| 2018 | 18 | 0 |
| 2019 | 17 | 0 |
| 2020 | 20 | 0 |
| 2021 | 11 | 0 |
| 2022 | 17 | 0 |
| 2023 | 18 | 0 |
| 2024 | 20 | 0 |
| 2025 | 20 | 1 |
| 2026 | 19 | 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.
1 device in this family has a Class I recall. 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 21.6 · 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 |
|---|---|---|---|
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 1…e Device: 21 CFR 807. 92(a)(3) Device Classification Name SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Regulation Number 892.2050 510(k) Number K992654 Device Name PLUG 'N VIEW 3D VOXAR LIMITED Applicant BONNINGTO… | 1999 |
What descends from it? (252)
See all 2524 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K051528 (Mevis Technology GmbH & Co. KG, 2005) has gone furthest, with 226 descendants of its own.
- 15 other devices also cite its predicate K992654.
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 VoxelPlusTMis a software application for the 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/K022692 · printed Nov 3, 2026
Cite this page
510(k) Report. “K022692: Voxelplus Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K022692
Report an extraction error
Are you the manufacturer?
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