# K253935: medXion NEXUS

- Pathway: 510(k) (Traditional)
- Applicant: medXion Technologies, Inc.
- Decided: May 15, 2026 after 157 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: 2 generations back to K190320 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193329: PreXion3D Explorer EX, Prexion Corporation (2020) Summary page 6.

## Indications for use
MedXion NEXUS is intended to produce three-dimensional digital X-ray images of the dental, oral, maxillofacial region, and ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. This device is not intended for use on patients less than approximately 21 kg (46 lb) 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. Use of equipment and exposure settings designed for adults of average size can result in excessive radiation exposure for a smaller patient. Studies have shown that pediatric patients may be more radiosensitive than adults (i.e., the cancer risk per unit dose of ionizing radiation is higher), and so unnecessary radiation exposure is of particular concern for pediatric patients.

Source page: https://510kreport.com/device/K253935
Methodology: https://510kreport.com/methodology