# K161881: PreXion3D Excelsior

- Pathway: 510(k) (Traditional)
- Applicant: Prexion Corporation
- Decided: Oct 3, 2016 after 87 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: 8 generations back to K973598 (1997). 30 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122199: PREXION3D Eclipse, The Yoshida Dental Mfg. Co., Ltd. (2013) Summary page 4.
- K103659: CS 9300, CS 9300C, Trophy (2011) Summary page 4.
- K133620: Cone Beam 3D and 2D Panoramic Dental Imaging System, Imaging Sciences International (2014) Summary page 4.

## Most influential descendants
- K173878: PreXion3D Excelsior (2018), 1 descendant of its own
- K181983: PreXion 3D Excelsior (2018), 0 descendants of its own

## Indications for use
PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial. and ENT (Ear. Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.

Source page: https://510kreport.com/device/K161881
Methodology: https://510kreport.com/methodology