# K213462: EzRay M18 (Model: VMX-P400)

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Feb 11, 2022 after 107 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 K040046 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182207: TR90BH, Minxray, Inc. (2018) Summary page 4.

## Indications for use
EzRay M18 (Model: VMX-P400) is a portable X-ray system, intended for use by a qualified/trained physician or technician to acquire X-ray images of the desired parts of a patient’s anatomy on adult and pediatric patients (including head, chest, abdomen, cervical spine, and extremities). The device may be used for handheld diagnostic imaging of body extremities. The system is subject to the following limitations of use when stand-mounted: - The device may be used for diagnostic imaging of the head, abdomen, cervical spine, or extremities. - The device may be used for imaging of the chest when used without a grid. This device is not intended for mammography.

Source page: https://510kreport.com/device/K213462
Methodology: https://510kreport.com/methodology