Dental x-ray image interpretive software

Intended purpose

The device is a radiological automated concurrent-read computer-assisted detection software intended to aid in the detection of interproximal calculus deposits on both bitewing and periapical radiographs. The device surrounds suspected calculus deposits with a bounding box. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of containing calculus deposits. 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 or patient history. The system is to be used by professionally trained and licensed dentists.