Primevision 3D

The Primevision 3D is a digital panoramic and cone beam computed tomography (CBCT) x-ray system for dental imaging. It creates digital exposures in the maxillofacial area for dentistry, pediatric dentistry, and hard tissue diagnostics within ENT medicine. The device uses a single imaging detector to collect data for both 2D panoramic and 3D CBCT imaging modes.

The Primevision 3D uses a single sensor for both 2D and 3D imaging, whereas the predicate Axeos used separate sensors. It incorporates cloud-based acquisition software accessed via a standard internet browser instead of on-premise software. Additional enhancements include motion and spine artifact compensation, and a revised hardware interface with simplified controls and an updated remote control with a hand switch. The 3D reconstruction method remains the same filtered back projection (FBP) approach as the predicate.

IEC 60601-1:2005 and amendments (medical electrical equipment safety), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-1-3:2008 (radiation protection), IEC 60601-2-63:2012 (dental x-ray equipment), IEC 62304:2006 (software lifecycle), IEC 62366-1:2015 (usability engineering), IEC 61223-3-4:2000 and IEC 61223-3-7:2021 (imaging performance acceptance tests for dental x-ray and CBCT equipment).

The device has identical intended use and indications for use as the predicate Axeos, and incorporates the same fundamental CBCT technology with the same 3D reconstruction method. Performance testing demonstrates substantially equivalent imaging performance across panoramic and CBCT modes per applicable consensus standards. New software features (motion and spine artifact compensation) were evaluated through comprehensive performance testing and clinical evaluation meeting prespecified success criteria. The omission of cephalometric imaging does not alter the intended use or raise new safety or effectiveness questions.