# K223058: EzRay Air 2 Wall (Model: VEX-S350W)

- Pathway: 510(k) (Special)
- Applicant: VATECH Co., Ltd.
- Decided: Oct 26, 2022 after 26 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000672 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163705: EzRay Air W, VATECH Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K250839: Dental X-ray System (2026), 0 descendants of its own

## Indications for use
The EzRay Air 2 Wall (Model Name: VEX-S350W) is a dental X-ray system intended for use by a trained and qualified dentist or dental technician for both adult and pediatric subjects for producing diagnostic dental radiographs for the treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.

Source page: https://510kreport.com/device/K223058
Methodology: https://510kreport.com/methodology