# K251438: Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )

- Pathway: 510(k) (Special)
- Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
- Decided: Sep 4, 2025 after 118 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: 7 generations back to K000061 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222569: Ai Ray Dental X-Ray Device, Guilin Woodpecker Medical Instrument Co., Ltd. (2022) Summary page 5.

## Indications for use
It 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/K251438
Methodology: https://510kreport.com/methodology