# K260236: XLITE

- Pathway: 510(k) (Traditional)
- Applicant: Gemss Healthcare CO., LTD.
- Decided: Aug 3, 2026 after 189 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)
- K143494: ADX6000 Portable X-Ray System; iRayA6, Dexcowin Co., Ltd. (2015) Summary page 5.

## Indications for use
The XLITE is a mobile diagnostic X-ray system intended for stand-mounted use by qualified and trained healthcare professionals to produce diagnostic radiographic images of the extremities in adult patients. The device is intended for extremity imaging only. The device is not intended for mammography.

Source page: https://510kreport.com/device/K260236
Methodology: https://510kreport.com/methodology