Tuxedo

Primary DI

00860008321312

Brand

Tuxedo

Company

Tuxedo Imaging LLC

Model

TUXEDO INTRAORAL SENSOR

Catalog number

6101A Size 2

Device description

This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.

Published

2022-03-23

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true