# K231757: Ez3D-i /E3

- Pathway: 510(k) (Special)
- Applicant: Ewoosoft Co., Ltd.
- Decided: Jul 14, 2023 after 28 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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
Longest line of descent: 4 generations back to K190791 (2019). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222069: Ez3D-i/E3, Ewoosoft Co., Ltd. (2022) Summary page 5.
- K211791: Ez3D-i/E3, Ewoosoft Co., Ltd. (2021) Summary page 7.

## Most influential descendants
- K251072: Segmentron Viewer (2025), 0 descendants of its own
- K250005: Clever One (2025), 0 descendants of its own

## Indications for use
Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.

Source page: https://510kreport.com/device/K231757
Methodology: https://510kreport.com/methodology