# K263033: Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)

- Pathway: 510(k) (Special)
- Applicant: Fussen Technology Co., Ltd.
- Decided: Sep 30, 2026 after 30 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: 16 generations back to K801623 (1980). 141 ancestors in all.
No later device cites it as a predicate yet.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251842: Dental Computed Tomography X-ray System, Fussen Technology Co., Ltd. (2025) Summary page 5.

## 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/K263033
Methodology: https://510kreport.com/methodology