# K190320: PreXion3D Explorer

- Pathway: 510(k) (Traditional)
- Applicant: Prexion Corporation
- Decided: Apr 15, 2019 after 61 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
No predicates in its family tree.
9 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K193329: PreXion3D Explorer EX (2020), 8 descendants of its own
- 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

Source page: https://510kreport.com/device/K190320
Methodology: https://510kreport.com/methodology