# K141451: VixWin Platinum

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Sciences International (Dba Gendex, LLC)
- Decided: Aug 26, 2014 after 85 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930527 (1993). 5 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060178: Vix Win Pro, Gendex Dental Systems (2006) Summary page 4.

## Most influential descendants
- K162799: Cliniview (2017), 13 descendants of its own
- K203156: DTX Studio Clinic (2020), 10 descendants of its own
- K213562: DTX Studio Clinic 3.0 (2022), 9 descendants of its own
- K233925: Relu Creator (2024), 6 descendants of its own
- K243989: Second Opinion® 3D (2025), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K141451
Methodology: https://510kreport.com/methodology