# K143494: ADX6000 Portable X-Ray System; iRayA6

- Pathway: 510(k) (Traditional)
- Applicant: Dexcowin Co., Ltd.
- Decided: Oct 5, 2015 after 300 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: 3 generations back to K945707 (1995). 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)
- K040046: Minxray, Model HF120/60H Powerplus, Minxray, Inc. (2004) Summary page 6.
- K052721: Minxray, Model HF100H+, Minxray, Inc. (2005) Summary page 6.

## Most influential descendants
- K260236: XLITE (2026), 0 descendants of its own
- K253244: AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) (2026), 0 descendants of its own

## Indications for use
The ADX6000 (also known as iRay A6) is a handheld and portable general purpose X-ray system. The device uses a variable tube current with voltage from 50-80 kVp and, therefore, is limited to taking diagnostic x-rays of extremities. It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. This device is not intended for mammography.

Source page: https://510kreport.com/device/K143494
Methodology: https://510kreport.com/methodology