# K223010: Portable X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: Jan 17, 2023 after 110 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172810: Port-X IV, Genoray Co., Ltd. (2018) Summary page 5.

## Indications for use
The Portable X-ray System is used as a portable, extra oral x-ray source for producing diagnostic x-ray images using conventional film, PSP (phosphor plates) or digital sensors. It is intended for adult and pediatric patients. This equipment is available only to trained and qualified dentist or dental technician.

Source page: https://510kreport.com/device/K223010
Methodology: https://510kreport.com/methodology