# K092171: Volux, Digital Extraoral Source X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Apr 26, 2010 after 279 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: 3 generations back to K003787 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033248: Hitachi CB Mercuray Dental Cone-Beam X-Ray System, Hitachi Medical Systems America, Inc. (2003) Summary page 1.
- K060892: Galileos, Sirona Dental Systems GmbH (2006) Summary page 2.

## Indications for use
The VOLUX consists of an x-ray device that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes dental and maxillofacial areas, for use in planning and diagnostic support. VOLUX comprises a package of PC software modules to expand TRIANA capabilities to handling 3D data. This includes 3D reconstructions, storage, retrieval, viewing and processing of 3D-image data.

Source page: https://510kreport.com/device/K092171
Methodology: https://510kreport.com/methodology