510(k) · Cleared
ClearedCybermed, Inc., V-Works
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cybermed, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 7, 2001 as substantially equivalent to K992654 (Voxar Limited, 1999) after a 14-day review. Its family tree reaches back 3 generations to 1996. 140 later devices descend from it.
- Decided
- Dec 7, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954678 (1996). 140 later devices descend from it, 3 citing it directly.
- 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 deviceK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- Descendant · cites it directly · 75 of its ownK033955 RTISTMirada Solutions, Ltd. · 2004
- Descendant · 2 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · cites it directly · 63 of its ownK053155 VimplantCybermed, Inc. · 2005
- Descendant · 2 generations on · 38 of its ownK070803 InvivodentalAnatomage, Inc. · 2007
- Descendant · 3 generations on · 37 of its ownK102687 Mirada RTMirada Medical, Ltd. · 2010
Showing 5 of 140 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 140 · See all- K033955RTISTMirada Solutions, Ltd. · 2004 · cites it directly75descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 2 generations on70descendants
- K053155VimplantCybermed, Inc. · 2005 · cites it directly63descendants
- K070803InvivodentalAnatomage, Inc. · 2007 · 2 generations on38descendants
- K102687Mirada RTMirada Medical, Ltd. · 2010 · 3 generations on37descendants
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) | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| +1 | K033955 | RTIST | Mirada Solutions, Ltd. | 2004 | — |
| +2 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +1 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| +2 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| +3 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 8 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 7 | 0 |
| 2017 | 8 | 0 |
| 2018 | 11 | 0 |
| 2019 | 8 | 0 |
| 2020 | 8 | 0 |
| 2021 | 12 | 0 |
| 2022 | 11 | 0 |
| 2023 | 11 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 3…ides functions, which are substantially equivalent to this product: CyberMed,Inc. PREDICATE DEVICE Characteristics Voxar Limited V-works™ Plug’n View 3D 510(k) number K992654 Type of Software Stand alone application program Stand alone application program Program Computer Platform | Pentium It or lli wi… | 1999 |
What descends from it? (140)
See all 1403 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K033955 (Mirada Solutions, Ltd., 2004) has gone furthest, with 75 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 V-works is a software application for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI or 3D Ultrasound. 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/K013878 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013878: Cybermed, Inc., V-Works.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013878
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026