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
A radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucencies on permanent teeth captured on periapical radiographs. The device provides additional aid for the dentist to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that considers other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists.