# K150217: Orthophos SL

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: May 8, 2015 after 98 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: 7 generations back to K973642 (1997). 16 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103711: Orthophos XG 3D / Ceph, Sirona Dental Systems GmbH (2011) Summary page 4.
- K123070: Galileos Family, Sirona Dental Systems GmbH (2013) Summary page 4.

## Most influential descendants
- 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
- K161131: FONA Pan/Ceph (2016), 0 descendants of its own

## Indications for use
The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry, including pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and for carpus exposures.

Source page: https://510kreport.com/device/K150217
Methodology: https://510kreport.com/methodology