# K192098: EzMobile

- Pathway: 510(k) (Traditional)
- Applicant: Ewoosoft Co., Ltd.
- Decided: Jan 20, 2020 after 168 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
EzMobile is dental imaging software that is intended to provide various tools for maxillofacial radiographic imaging. These tools are available to view a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzZMobile is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

Source page: https://510kreport.com/device/K192098
Methodology: https://510kreport.com/methodology