Dental x-ray image interpretive software

Intended purpose

DS Core Detect is a concurrent read, computer assisted detection software intended to aid the dentist in the incidental detection of permanent teeth that may be associated with periapical radiolucencies in CBCT images. The device is not intended as a replacement for a complete dentist’s review or a replacement of their clinical judgement. The device is to be used by licensed dentists. The device is designed for patients who already have CBCT data obtained for other reasons. DS Core Detect does not generate X-ray images and does not provide an indication for taking such images. The device is intended for adults aged 22 years and older with permanent teeth.