Clever One

GUDID 08800019700593

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.

EWOO SOFT Co., Ltd

General-purpose dental x-ray system application software

• Primary Device ID: 08800019700593
• NIH Device Record Key: 723bc218-9093-4a1f-adee-84c41f2d3024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clever One
• Version Model Number: 1.0
• Company DUNS: 688379797
• Company Name: EWOO SOFT Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800019700593 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250005

FDA Product Code

• QIH: Automated Radiological Image Processing Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-05
• Device Publish Date: 2025-05-28

Devices Manufactured by EWOO SOFT Co., Ltd

• 08800019700593 - Clever One: 2025-06-05Clever 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.
• 08800019700593 - Clever One: 2025-06-05 Clever One is a dental imaging software designed to acquire, process, view, edit, and analyze medical images for supporting diag
• 08800019700531 - EzDent-i: 2024-08-21 EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These t
• 08800019700401 - Ez3D-i: 2023-08-03 Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These too
• 08800019700395 - EzDent Web: 2023-07-24 EzDent Web is a dental imaging software that enables you to save, manage, view and process patients’ images. EzDent Web is equ
• 08800019700388 - EzDent-i: 2023-03-15 EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These t
• 08800019700319 - EzOrtho: 2022-10-21 EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogra
• 08800019700340 - Ez3D-i: 2022-10-21 Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These too
• 08800019700357 - EzDent-i: 2022-10-21 EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These t