# K181983: PreXion 3D Excelsior

- Pathway: 510(k) (Special)
- Applicant: Prexion Corporation
- Decided: Aug 17, 2018 after 23 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: 10 generations back to K973598 (1997). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173878: PreXion3D Excelsior, Prexion Corporation (2018) Summary page 4.

## 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 dental (oral), 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/K181983
Methodology: https://510kreport.com/methodology