Device Dossier
Cone beam computed tomography system, head/neck
Device Dossier for Cone beam computed tomography system, head/neck (Cone beam computed tomography system, head/neck, Class IIb, sponsor Ray). ARTG…
- GMDN category: Cone beam computed tomography system, head/neck
Intended purpose
Device is a CBCT and panoramic x-ray imaging system with cephalometric. Which is intended for radiographic examination of the dento-maxillofacial, sinus and TMJ structure for diagnostic support for adult and pediatric patients. Cephalometric image also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified health care professionals.