Cone Beam 3D and 2D Panoramic Dental Imaging System
Intended Use/Indications For Use:
Devices of the i-CAT family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning, sinuses, airway), for use in planning and diagnostic support in adult and pediatric care.
Devices of the i-CAT family comprise a package of software modules capable of handling 2D and 3D data. This includes 3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data.
CAUTION: U.S. Federal Law (USA) restricts the sale of this device to or on the order of a dentist or other licensed practitioner.
Indications for Use:
Tx STUDIO is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologists, clinicians, referring physicians, and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute images, utilizing standard PC hardware. Additionally, Tx STUDIO is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning, and surgical treatments.
This device is not indicated for mammography use.