# K222569: Ai Ray Dental X-Ray Device

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
- Decided: Nov 23, 2022 after 91 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: 6 generations back to K000061 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200182: EzRay Air Portable (Model: VEX-P300), VATECH Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K251438: Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (2025), 0 descendants of its own

## Indications for use
Ai Ray Dental X-Ray Device is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dentist or a dental technician for both adult and pediatric patients.

Source page: https://510kreport.com/device/K222569
Methodology: https://510kreport.com/methodology