# K092772: Portable X-Ray System, Model Hand-Ray

- Pathway: 510(k) (Traditional)
- Applicant: Hanjin Digi-X Co., Ltd.
- Decided: Jan 6, 2010 after 119 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: 5 generations back to K000061 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063121: Portable X-Ray System, Model Port-X II, Genoray Co., Ltd. (2007) Summary page 1.
- K082167: Portable X-Ray System, Models Diox-602, Prox, Digimed Corporation (2008) Summary page 2.

## Indications for use
The Portable X-ray System (Model: HAND-RAY) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Source page: https://510kreport.com/device/K092772
Methodology: https://510kreport.com/methodology