510(k) · Cleared
ClearedPlug 'N View 3D, Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voxar Limited · LLZ System, Image Processing, Radiological
Cleared on Nov 5, 1999 as substantially equivalent to K980648 (Algotec Systems, Ltd., 1998) after an 88-day review. Its family tree reaches back 2 generations to 1996. 1 of the 673 devices in its family, counting itself, has a Class I recall. 670 later devices descend from it.
- Decided
- Nov 5, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954678 (1996). 670 later devices descend from it, 16 citing it directly. 1 of the 673 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 1 generation backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- This deviceK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- Descendant · cites it directly · 442 of its ownK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- Descendant · cites it directly · 252 of its ownK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- Descendant · 2 generations on · 226 of its ownK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- Descendant · 3 generations on · 217 of its ownK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- Descendant · 2 generations on · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
Showing 5 of 670 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 670 · See all- K020546Fusion 7DMirada Solutions, Ltd. · 2002 · cites it directly442descendants
- K022692Voxelplus PacsMevisys Co., Ltd. · 2002 · cites it directly252descendants
- K051528Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005 · 2 generations on226descendants
- K061696Iqqa-Liver SoftwareEdda Technology, Inc. · 2006 · 3 generations on217descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on201descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −1 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| 0 (this device) | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| +1 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| +1 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| +2 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| +3 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| +2 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 10 | 0 |
| 2006 | 16 | 0 |
| 2007 | 12 | 0 |
| 2008 | 16 | 0 |
| 2009 | 18 | 0 |
| 2010 | 10 | 0 |
| 2011 | 16 | 0 |
| 2012 | 28 | 0 |
| 2013 | 22 | 0 |
| 2014 | 29 | 0 |
| 2015 | 26 | 0 |
| 2016 | 29 | 0 |
| 2017 | 34 | 0 |
| 2018 | 38 | 0 |
| 2019 | 31 | 0 |
| 2020 | 39 | 0 |
| 2021 | 32 | 0 |
| 2022 | 41 | 0 |
| 2023 | 45 | 0 |
| 2024 | 47 | 0 |
| 2025 | 59 | 1 |
| 2026 | 50 | 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 21.5 · 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 |
|---|---|---|---|
| * | K980648 | Pro VisionSummary page 1…unications System (Image Processing Sub-System) (892.2050) Image processing, management and 3D visualization system Plug ‘n View 3D Pro Vision Diagnostic Workstation (K980648), manufactured by Algotec Systems Ltd. 6. Device Description and Intended Use Plug ‘n View 3D is a software application for th… | 1998 |
What descends from it? (670)
See all 67016 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 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K020546 (Mirada Solutions, Ltd., 2002) has gone furthest, with 442 descendants of its own.
- 1 other device also cites its predicate K980648.
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?
Plug ‘n View 3D is a software application for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
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/K992654 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992654: Plug 'N View 3D, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992654
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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