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FDA-cleared K250005

Clever One

Ewoosoft Co., Ltd

Authorized purpose: Clever One is dental imaging software for trained professionals to view and interpret DICOM images from CT, panoramic, cephalometric, intraoral, and other imaging equipment, with two-dimensional analysis and three-dimensional visualization tools.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Dental and craniomaxillofacial anatomy
Decision
2025-05-23
FDA-cleared K231757

Ez3D-i /E3

Ewoosoft Co., Ltd

Authorized purpose: Ez3D-i/E3 provides dental and maxillofacial DICOM viewing, three-dimensional visualization, multiplanar reconstruction, two-dimensional analysis, implant simulation, canal tracing, and bone-density tools for trained radiologists and dentists.

Modality
CBCT
Anatomy
Dental/Maxillofacial
Decision
2023-07-14