# K060178: Vix Win Pro

- Pathway: 510(k) (Traditional)
- Applicant: Gendex Dental Systems
- Decided: Mar 10, 2006 after 46 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930527 (1993). 4 ancestors in all.
35 later devices descend from it; 6 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012439: Dentaleye 2 Dental Image Management System, Radco Data AB (2002) Summary page 1.
- K050744: Kavo Ergocom/Ergocam, Kavo America Corporation (2005) Summary page 2.

## Most influential descendants
- K141451: VixWin Platinum (2014), 14 descendants of its own
- K131594: Ezdenti-I; E2; Prora View (2013), 14 descendants of its own
- K162799: Cliniview (2017), 13 descendants of its own
- K150747: EzDent-i /E2/Prora View (2015), 13 descendants of its own
- K161117: EzDent-i / E2 / Prora View (2016), 12 descendants of its own

## Recalls of this device
- Mar 6, 2009 · Not classified · Z-1548-2009: 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, resul

## Indications for use
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.

Source page: https://510kreport.com/device/K060178
Methodology: https://510kreport.com/methodology