510(k) · Cleared
Recalled · 2009Vix Win Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gendex Dental Systems · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Mar 10, 2006 as substantially equivalent to K012439 (Radco Data AB, 2002) and 1 other predicate after a 46-day review. Its family tree reaches back 4 generations to 1993. 35 later devices descend from it. It has been recalled once.
- Decided
- Mar 10, 2006
- Review
- 46 days
- Class
- Class II
- Product code
- MUH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930527 (1993). 35 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK930527 Dental LinkEscan, Inc. · 1993
- 3 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 2 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 1 generation backK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- This deviceK060178 Vix Win ProGendex Dental Systems · 2006
- Descendant · cites it directly · 14 of its ownK141451 VixWin PlatinumImaging Sciences International (Dba Gendex, LLC) · 2014
- Descendant · cites it directly · 14 of its ownK131594 Ezdenti-I; E2; Prora ViewEwoosoft Co., Ltd. · 2013
- Descendant · 2 generations on · 13 of its ownK162799 CliniviewPalodex Group OY · 2017
- Descendant · 2 generations on · 13 of its ownK150747 EzDent-i /E2/Prora ViewLK Consulting Group USA, Inc. · 2015
- Descendant · 3 generations on · 12 of its ownK161117 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2016
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K141451VixWin PlatinumImaging Sciences International (Dba Gendex, LLC) · 2014 · cites it directly14descendants
- K131594Ezdenti-I; E2; Prora ViewEwoosoft Co., Ltd. · 2013 · cites it directly14descendants
- K162799CliniviewPalodex Group OY · 2017 · 2 generations on13descendants
- K150747EzDent-i /E2/Prora ViewLK Consulting Group USA, Inc. · 2015 · 2 generations on13descendants
- K161117EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2016 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −3 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −2 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −1 | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| 0 (this device) | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | — |
| +1 | K141451 | VixWin Platinum | Imaging Sciences International (Dba Gendex, LLC) | 2014 | — |
| +1 | K131594 | Ezdenti-I; E2; Prora View | Ewoosoft Co., Ltd. | 2013 | — |
| +2 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| +2 | K150747 | EzDent-i /E2/Prora View | LK Consulting Group USA, Inc. | 2015 | — |
| +3 | K161117 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 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 |
|---|---|---|---|
| * | K012439 | Dentaleye 2 Dental Image Management SystemSummary page 1…Z or System, x-ray, extraoral source, digital Product Code MIJH Common/Usual Name: Dental Image Management System 2. Equivalent legally marketed device: DentalEye 2, K012439 and KaVo ERGOcorn®/ERGOcam® K(050744. 3I Indications for Use (intended use): VixWin PRO controls capture, display, treatmen… | 2002 |
| * | K050744 | Kavo Ergocom/ErgocamSummary page 2…KaVo ERGOcom® VixWin Pro K012439 /ERGOcam® K050744 Implementation Software only Hardware and Software Software only… | 2005 |
What descends from it? (35)
See all 356 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2009 | Not classified | Z-1548-2009 | Software design | There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction with Easy Dental, PracticeWorks, EagleSoft and SoftDent practice management software, resulting in patient files that may contain… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K141451 (Imaging Sciences International (Dba Gendex, LLC), 2014) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K012439.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
VixWin PRO controls capture, display, treatment, analysis and saving of X-ray digital images from DenOptix®, Visualix®/GX-S, Orthoralix 9200 DPI and DDE digital imaging systems produced by Gendex. It can also handle other types of digital images, e.g. color images from an intraoral or extraoral dental camera, such as the Gendex Concept IV series, or images acquired by digitizing film with a flat bed scanner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060178 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060178: Vix Win Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060178
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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