# K260662: Dental Cone Beam Computed Tomography System

- Pathway: 510(k) (Special)
- Applicant: Yofo Medical Technology Co., Ltd.
- Decided: Jun 4, 2026 after 94 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: 10 generations back to K973642 (1997). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243337: Dental Cone Beam Computed Tomography System, Yofo Medical Technology Co., Ltd. (2025) Summary page 5.

## Indications for use
The Dental Cone Beam Computed Tomography System is intended to be used by medical institutions for X-ray image diagnosis on oral and maxillofacial areas through X-ray Cone Beam Computed Tomography (CBCT).

Source page: https://510kreport.com/device/K260662
Methodology: https://510kreport.com/methodology