# K190935: EZER, Portable X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Livermoretech, Inc.
- Decided: Dec 19, 2019 after 253 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K134055 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134055: ADX4000W, Dexcowin Co., Ltd. (2014) Summary page 4.

## Indications for use
EZER Portable X-Ray system is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Source page: https://510kreport.com/device/K190935
Methodology: https://510kreport.com/methodology