# K232068: HyperLight Portable X-ray Unit

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Sifary Medical Technology Co., Ltd.
- Decided: Sep 1, 2023 after 51 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). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180561: MobileX Portable X-ray System, Denterprise International, Inc. (2018) Summary page 5.

## Most influential descendants
- K260795: Hand-held Dental X-ray System (HyperLight-M) (2026), 0 descendants of its own
- K254018: Portable Dental X-ray Device (GT-1) (2026), 0 descendants of its own

## Indications for use
The HyperLight Portable X-ray Unit 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/K232068
Methodology: https://510kreport.com/methodology