# K103711: Orthophos XG 3D / Ceph

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Mar 22, 2011 after 92 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: 3 generations back to K972312 (1997). 7 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 15 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.
- K033073: Orthophos XG DS/Ceph, Sirona Dental Systems GmbH (2003) Summary page 1.

## Most influential descendants
- K150217: Orthophos SL (2015), 5 descendants of its own
- K201140: Axeos (2020), 1 descendant of its own
- K253959: Primevision 3D (2026), 0 descendants of its own
- K213579: Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph (2022), 0 descendants of its own
- K191616: Orthophos S (2019), 0 descendants of its own

## Indications for use
The ORTHOPHOS XG 3D/ Ceph is intended to produce two dimensional images and three dimensional volume reconstructions, including partial volumes and selected projections of the dentomaxillofacial areas, for use in planning and diagnostic support. Image acquisition, modes include panoramic X-ray, cephalometric X-ray, specialized tomographic X-ray, and cone beam tomography X-ray. The system can also acquire carpal exposures. The system includes an X-ray source, flat panel X-ray detector, positioning devices, as well as interactive 3D reconstruction, processing, and archiving software.

Source page: https://510kreport.com/device/K103711
Methodology: https://510kreport.com/methodology