Dental x-ray image interpretive software

Intended purpose

A radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment. The intended patient population of the device is patients that have primary and mixed dentition, and are 4-11 years old. The target users are professionally trained and licensed dentists.