# K193535: EZER, Portable X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Livermoretech, Inc.
- Decided: May 7, 2020 after 139 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.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140723: Nomad MD 75K V Handheld X-Ray System, Aribex, Inc. (2014) Summary page 4.

## Most influential descendants
- K244049: Europa (Alternative: AiRTouch) portable X-ray system (2025), 0 descendants of its own
- K234108: ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) (2024), 0 descendants of its own

## Indications for use
EZER Portable X-Ray system is a portable x-ray source with a fixed tube current and voltage for producing diagnostic x-ray images of extremities using digital or film image receptors. Its use is intended to be used by trained clinician or technicians for both adult and pediatric subjects age 2 and above. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.

Source page: https://510kreport.com/device/K193535
Methodology: https://510kreport.com/methodology