# K252110: Dental X-RAY Unit (AJX200)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Ajax Medical Equipment Co., Ltd.
- Decided: Mar 12, 2026 after 248 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.
No later device cites it as a predicate yet.
0 of 7 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 6.

## Indications for use
The Unit is an extraoral source dental radiographic x-ray unit. This unit works as diagnostic purpose x-ray source for human teeth with resultant image recorded on intraoral dental x-ray film or image receptor. The unit is intended to be used in a dental hospital or general hospital with a dental office and should have a separate space to install and use this product. The device is intended to be used for adult and pediatric patients.

Source page: https://510kreport.com/device/K252110
Methodology: https://510kreport.com/methodology