# K232166: PreXion3D Expedition

- Pathway: 510(k) (Traditional)
- Applicant: Prexion Corporation
- Decided: Sep 8, 2023 after 49 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: 4 generations back to K190320 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222150: PreXion3D Expedition, Prexion Corporation (2023) Summary page 4.

## Indications for use
PreXion3D Expedition is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck 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. This device is not intended for use on patients less than approximately 21 kg (46 Ib) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

Source page: https://510kreport.com/device/K232166
Methodology: https://510kreport.com/methodology