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 Dentsply Sirona). ARTG record,…
- GMDN category: Dental x-ray image interpretive software
- Sponsor: Dentsply Sirona
Intended purpose
"DS Core CBCT Anatomy" is a cloud-based AI/ML enabled software as a medical device. The device is available as a backend service via an API (Application Programming Interface). The device is intended to be used by dental professionals when reviewing Digital Impression (DI) scans and CBCT (DX) scans during standard of care diagnostic review and treatment planning. DS Core CBCT Anatomy analyses CBCT scans and Digital Impression (DI) scans to identify anatomical structures and to provide image registration between scans for dental use.