# K203784: PreXion3D Explorer PRO

- Pathway: 510(k) (Traditional)
- Applicant: Prexion Corporation
- Decided: Feb 23, 2021 after 57 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.
6 later devices descend from it; 2 cite it directly.
0 of 9 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 5.
- K190320: PreXion3D Explorer, Prexion Corporation (2019) Summary page 5.

## Most influential descendants
- 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
- K251642: Dental CBCT X-ray System (2025), 0 descendants of its own
- K240855: Dental Cone-beam Computed Tomography (2024), 0 descendants of its own

## Indications for use
PreXion3D Explorer PRO 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.

Source page: https://510kreport.com/device/K203784
Methodology: https://510kreport.com/methodology