# K251842: Dental Computed Tomography X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Fussen Technology Co., Ltd.
- Decided: Nov 13, 2025 after 150 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: 15 generations back to K801623 (1980). 140 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230985: Planmeca Viso, Planmeca Oy (2023) Summary page 5.

## Most influential descendants
- K263033: Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (2026), 0 descendants of its own

## Indications for use
The product is intended to produce X-ray Cone-Beam Computed Tomography, Panoramic tomography and Cephalometric (optional) images. The medical institutions can use the images for diagnostic purposes in oral and maxillofacial regions.The product is intended for use in hospitals and clinics, operated and used by trained professionals under the guidance of a physician.

Source page: https://510kreport.com/device/K251842
Methodology: https://510kreport.com/methodology