# K244049: Europa (Alternative: AiRTouch) portable X-ray system

- Pathway: 510(k) (Traditional)
- Applicant: Livermoretech, Inc.
- Decided: May 28, 2025 after 148 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: 5 generations back to K945707 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193535: EZER, Portable X-ray System, Livermoretech, Inc. (2020) Summary page 5.

## Indications for use
Europa (Alternative: AiRTouch) portable X-ray system is intended for use by trained or qualified doctors to produce diagnostic X-ray images of extremities in adult and pediatric(over 12 years old) patients. These images are obtained using anatomical structures captured by film or image processing systems (workstation) after an examination involving radiation exposure with cassette IP, CR, or DR (portable flat panel). Only intended for stand-mounted use.

Source page: https://510kreport.com/device/K244049
Methodology: https://510kreport.com/methodology