# K123070: Galileos Family

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Mar 15, 2013 after 165 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K973642 (1997). 10 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060892: Galileos, Sirona Dental Systems GmbH (2006) Summary page 1.
- K120263: Volux 21C, Digital Extraoral Source X-Ray System, Genoray Co., Ltd. (2012) Summary page 1.

## Most influential descendants
- 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
- K243337: Dental Cone Beam Computed Tomography System (2025), 1 descendant of its own

## Indications for use
Devices of the GALILEOS family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support in adult and pediatric care. Devices of the GALILEOS family comprise a package of PC software modules to expand SIDEXIS capabilities to handling 3D data. This includes 3D reconstruction, storage, retrieval, viewing and processing of 3D-image data.

Source page: https://510kreport.com/device/K123070
Methodology: https://510kreport.com/methodology