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FDA-cleared K252934

Diagnocat

DGNCT, LLC

Authorized purpose: Diagnocat is an automated concurrent-read aid for detecting periapical radiolucency on permanent teeth in previously acquired, clinically justified maxillofacial CBCT; it is a second-read aid and does not replace complete dental-professional review or judgment.

Modality
CBCT
Anatomy
Maxillofacial region; permanent teeth; periapical radiolucency
Decision
2026-01-15
FDA-cleared K251072

Segmentron Viewer

DGNCT, LLC

Authorized purpose: Segmentron Viewer is an AI web application for processing and manipulating maxillofacial radiographic images, viewing and segmenting three-dimensional CBCT data, and creating editable STL outputs for educational use.

Modality
CBCT
Anatomy
Maxillofacial anatomy and permanent dentition
Decision
2025-09-09