# K122124: Portable X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: May 16, 2013 after 302 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: 4 generations back to K000061 (2000). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 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.

## Most influential descendants
- K180671: MINE (2019), 0 descendants of its own
- K141497: Portable X-Ray System (Model:Exaro,XRAY2GO) (2014), 0 descendants of its own

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

Source page: https://510kreport.com/device/K122124
Methodology: https://510kreport.com/methodology