Clever One
- Primary DI
- 08800019700593
- Brand
- Clever One
- Company
- EWOO SOFT Co., Ltd
- Model
- 1.0
- Device description
- Clever One is a dental imaging software designed to acquire, process, view, edit, and analyze medical images for supporting diagnostic and preoperative planning purposes. It supports standard DICOM formats for 2D and 3D image files and enables advanced imaging functionalities for enhanced diagnostic accuracy.The software provides a range of features, including:- 2D Imaging: Loading, editing, and viewing 2D dental images in standard formats (e.g., DICOM, JPG, BMP).- 3D Imaging: Visualization and reconstruction of 3D CT images, including multi-planar views (MPR) and volume rendering.- Preoperative Planning: Implant position simulation, canal drawing, and bone density analysis to support treatment planning.- Data Interoperability: Facilitates data transfer and storage using DICOM-compliant workflows, ensuring compatibility with third-party systems and imaging devices.The software interfaces with dental imaging equipment, such as CT, panoramic, cephalometric, and intraoral X-ray systems, as well as intraoral cameras, for image acquisition. It is designed for use in network environments, allowing users to upload and download clinical diagnostic images and patient data for enhanced collaboration and efficient patient management.
- Published
- 2025-05-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| QIH | Automated Radiological Image Processing Software |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Radiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K250005 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08800019700593 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08800019700593 | 08800019700593 | 8800019700593 |
GMDN Terms#
| Term | Definition |
|---|---|
| General-purpose dental x-ray system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 688379797
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08800019700531 | EzDent-i | 3.5 | 2024-08-13 | |
| 08800019700401 | Ez3D-i | 5.5 | 2023-07-26 | |
| 08800019700395 | EzDent Web | v1.2 | 2023-07-14 | |
| 08800019700388 | EzDent-i | 3.4 | 2023-03-07 | |
| 08800019700319 | EzOrtho | 1.3 | 2022-10-13 | |
| 08800019700340 | Ez3D-i | 5.4 | 2022-10-13 | |
| 08800019700357 | EzDent-i | 3.3 | 2022-10-13 | |
| 08800019700227 | EzDent-i | v3.2 | 2021-11-08 | |
| 08800019700234 | Ez3D-i | v5.3 | 2021-11-08 | |
| 08800019700241 | EzDent Web | v1.0 | 2021-11-08 | |
| 08800019700258 | EzOrtho | 1.2 | 2021-11-08 | |
| 08800019700081 | OrthoVision | v2.1 | 2020-12-15 | |
| 08800019700159 | EzOrtho | 1.0 | 2020-11-25 | |
| 08800019700173 | Ez3D-i | v5.2 | 2020-11-25 | |
| 08800019700203 | EzOrtho | 1.1 | 2020-11-25 | |
| 08800019700197 | EzDent-i | v3.1 | 2020-09-14 | |
| 08800019700180 | Smart M Viewer | v3.0 | 2020-05-07 | |
| 08800019700142 | EzMobile | v1.1 | 2020-02-05 | |
| 08800019700128 | Ez3D-i | v5.1 | 2019-05-31 | |
| 08800019700111 | EzDent-i | v3.0 | 2019-05-20 |
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