PREXION EVOLVE

Device typeCone beam computed tomography system, head/neck: A stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.

FDA categoryX-Ray, Tomography, Computed, Dental

Device ID07899581345067

Catalog number16000004495

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information