# K060892: Galileos

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Apr 14, 2006 after 11 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: 2 generations back to K003787 (2001). 2 ancestors in all.
17 later devices descend from it; 3 cite 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)
- K033248: Hitachi CB Mercuray Dental Cone-Beam X-Ray System, Hitachi Medical Systems America, Inc. (2003) Summary page 1.

## Most influential descendants
- K123070: Galileos Family (2013), 13 descendants of its own
- K103711: Orthophos XG 3D / Ceph (2011), 7 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

## Indications for use
GALILEOS 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 ENT and dcentomaxillofacial areas, for use in planning and diagnostic support. GALILEOS comprises 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/K060892
Methodology: https://510kreport.com/methodology