Device Dossier
Dental x-ray image interpretive software
Device Dossier for Dental x-ray image interpretive software (Dental x-ray image interpretive software, Class IIa, sponsor Emergo). ARTG record, intended…
- GMDN category: Dental x-ray image interpretive software
Intended purpose
The device is a radiological automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. It is a cloud native Software as a Medical Device that allows users to automate the measurement of bone levels for bitewing and periapical radiographs, review associated radiographs, view annotations, and modify annotations.