510(k) · Cleared
ClearedVixWin Platinum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Sciences International (Dba Gendex, LLC) · LLZ System, Image Processing, Radiological
Cleared on Aug 26, 2014 as substantially equivalent to K060178 (Gendex Dental Systems, 2006) after an 85-day review. Its family tree reaches back 5 generations to 1993. 14 later devices descend from it.
- Decided
- Aug 26, 2014
- Review
- 85 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930527 (1993). 14 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK930527 Dental LinkEscan, Inc. · 1993
- 4 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 3 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 2 generations backK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- 1 generation backK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
- This deviceK141451 VixWin PlatinumImaging Sciences International (Dba Gendex, LLC) · 2014
- Descendant · cites it directly · 13 of its ownK162799 CliniviewPalodex Group OY · 2017
- Descendant · 2 generations on · 10 of its ownK203156 DTX Studio ClinicNobel Biocare AB · 2020
- Descendant · 3 generations on · 9 of its ownK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- Descendant · 4 generations on · 6 of its ownK233925 Relu CreatorRelu BV · 2024
- Descendant · 5 generations on · 3 of its ownK243989 Second Opinion® 3DPearl, Inc. · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K162799CliniviewPalodex Group OY · 2017 · cites it directly13descendants
- K203156DTX Studio ClinicNobel Biocare AB · 2020 · 2 generations on10descendants
- K213562DTX Studio Clinic 3.0Nobel Biocare AB · 2022 · 3 generations on9descendants
- K233925Relu CreatorRelu BV · 2024 · 4 generations on6descendants
- K243989Second Opinion® 3DPearl, Inc. · 2025 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −4 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −3 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −2 | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| −1 | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | 1 |
| 0 (this device) | K141451 | VixWin Platinum | Imaging Sciences International (Dba Gendex, LLC) | 2014 | — |
| +1 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| +2 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| +3 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| +4 | K233925 | Relu Creator | Relu BV | 2024 | — |
| +5 | K243989 | Second Opinion® 3D | Pearl, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K060178 | Vix Win ProSummary page 4…mmon or Usual Name Dental Imaging Device Product Code LLZ Classification Name System, Image Processing, Radiology, per 21 CFR §892.2050. Predicate Devices VixWin PRO (K060178) Intended Use / Indications for Use VixWin Platinum is a software program for general dental and maxillofacial diagnostic imagin… | 2006 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162799 | Cliniview | 2017 | 13 |
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 21 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K162799 (Palodex Group OY, 2017) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K060178.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141451: VixWin Platinum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141451
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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