# K250005: Clever One

- Pathway: 510(k) (Traditional)
- Applicant: Ewoosoft Co., Ltd.
- Decided: May 23, 2025 after 141 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: 16 generations back to K930527 (1993). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241114: EzDent-i / E2 / Prora View / Smart M Viewer (v3.5), Ewoosoft Co., Ltd. (2024) Summary page 5.
- K231757: Ez3D-i /E3, Ewoosoft Co., Ltd. (2023) Summary page 5.

## Indications for use
Clever One is dental imaging software that is intended to provide tools for supporting diagnosis and treatment. These tools enable end users to view and interpret a series of DICOM compliant medical images and are intended for use by trained medical professionals. Clever One allows users to load, view, and save DICOM images from CT, panoramic, cephalometric, intraoral, and other imaging equipment. It also provides functionalities such as 2D viewing, 2D analysis, 3D visualization, 3D analysis.

Source page: https://510kreport.com/device/K250005
Methodology: https://510kreport.com/methodology