# K120263: Volux 21C, Digital Extraoral Source X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Jul 10, 2012 after 162 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- 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 K973642 (1997). 6 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102124: Dental Computed Tomography X-Ray System, VATECH Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K123070: Galileos Family (2013), 13 descendants of its own
- K133620: Cone Beam 3D and 2D Panoramic Dental Imaging System (2014), 6 descendants of its own
- K150217: Orthophos SL (2015), 5 descendants of its own
- K162085: i-CAT FLX V series / KaVo 3D eXam+ V series (2016), 2 descendants of its own
- K161881: PreXion3D Excelsior (2016), 2 descendants of its own

## Indications for use
VOLUX 21IC is a Computed tomography X-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral and cranjoifacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic images of the anatomic structures by acquiring 360 rotational image sequences of oral and craniofacial area for a precise treatment planning in adult and pediatric care. The device is operated and used by physicians, dentists and x-ray technicians.

Source page: https://510kreport.com/device/K120263
Methodology: https://510kreport.com/methodology