# K243337: Dental Cone Beam Computed Tomography System

- Pathway: 510(k) (Traditional)
- Applicant: Yofo Medical Technology Co., Ltd.
- Decided: Apr 17, 2025 after 174 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: 9 generations back to K973642 (1997). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162085: i-CAT FLX V series / KaVo 3D eXam+ V series, Imaging Sciences International (2016) Summary page 5.

## Most influential descendants
- K260662: Dental Cone Beam Computed Tomography System (2026), 0 descendants of its own

## 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/K243337
Methodology: https://510kreport.com/methodology