# K151038: EPX-Series Mobile X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Ecotron Co., Ltd.
- Decided: Jul 24, 2015 after 95 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- 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 K945707 (1995). 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)
- K122697: Porta 100HF, Job Corporation (2012) Summary page 5.

## Indications for use
This product, diagnostic X-ray system, is radiation medical equipment used by a qualified / trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays. This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts.

Source page: https://510kreport.com/device/K151038
Methodology: https://510kreport.com/methodology