# K254018: Portable Dental X-ray Device (GT-1)

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Refine Medical Instrument Co., Ltd.
- Decided: Feb 19, 2026 after 66 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: 8 generations back to K000061 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232068: HyperLight Portable X-ray Unit, Changzhou Sifary Medical Technology Co., Ltd. (2023) Summary page 5.

## Indications for use
The Portable Dental X-ray Device is intended to be used by dental professionals to provide an extraoral X-ray source to produce radiographic images of the teeth using intraoral image receptors for clinical diagnostic purposes.

Source page: https://510kreport.com/device/K254018
Methodology: https://510kreport.com/methodology