Clever One
EWOO SOFT Co., Ltd · Model 1.0 · UDI-DI 08800019700593
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-07 | PIE Medical Imaging B.V. | User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d |
| 2021-05-19 | Caption Health | The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoE |
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