# K193329: PreXion3D Explorer EX

- Pathway: 510(k) (Traditional)
- Applicant: Prexion Corporation
- Decided: Apr 9, 2020 after 129 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: 1 generation back to K190320 (2019). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190320: PreXion3D Explorer, Prexion Corporation (2019) Summary page 5.

## Most influential descendants
- K203784: PreXion3D Explorer PRO (2021), 6 descendants of its own
- K221525: PreXion3D Explorer PRO (2022), 3 descendants of its own
- K232710: Dental Cone-beam Computed Tomography (2024), 2 descendants of its own
- K222150: PreXion3D Expedition (2023), 1 descendant of its own
- K253935: medXion NEXUS (2026), 0 descendants of its own

## Indications for use
PreXion3D Explorer EX is intended to produce two-dimensional digital x-ray images including panoramic 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. 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/K193329
Methodology: https://510kreport.com/methodology