Intended Use/Indications For Use:
The Imaging Sciences International Inc. i-CAT scanner construct a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
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 iis 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.