# K260795: Hand-held Dental X-ray System (HyperLight-M)

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Sifary Medical Technology Co., Ltd.
- Decided: Sep 14, 2026 after 187 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 device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.

Source page: https://510kreport.com/device/K260795
Methodology: https://510kreport.com/methodology