Clever One
Ewoosoft Co., LtdClever One is dental imaging software designed to acquire, process, view, and analyze 2D and 3D medical images from dental CT, panoramic, cephalometric, and intraoral imaging devices. It helps clinicians by providing advanced visualization and analytic tools such as bone density analysis, implant planning, and multi-planar reconstructions, facilitating more accurate diagnostics and treatment plans.
Intended Use
Clever One is dental imaging software intended to provide tools for supporting diagnosis and treatment, enabling trained medical professionals to view, interpret, and analyze DICOM compliant medical images from CT, panoramic, cephalometric, intraoral, and other dental imaging equipment.
Technology
Clever One processes 2D and 3D dental images in standard DICOM format, supports 3D visualization, multi-planar reconstructions, implant simulation, canal drawing, bone density analysis, and works in network environments for image and data sharing.
Performance
Software verification and validation tests and measurement accuracy tests were conducted, meeting all predetermined criteria. Cybersecurity risk management and validation were also performed in compliance with FDA guidance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/2/2025
4 months - 2
FDA Approval
5/23/2025
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