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The SOTA Cloud Smart Sensor is a digital intraoral X-ray sensor intended for use in dental practices that utilize X-ray equipment for intraoral diagnostic purposes. The device is intended to be used by trained dental professionals for patients receiving intraoral X-ray examinations and produces digital images that can be displayed and archived digitally.

The SOTA Cloud Smart Sensor is a USB-powered, solid-state digital intraoral X-ray detector intended for use in dental practices. The device is a static detector. X-rays are generated by an external dental X-ray generator. The x-ray generator, an essential component of a fully functional dental imaging system, is not part of the submission.

The device utilizes an indirect detection architecture consisting of:

• Cesium Iodide (CsI) scintillator
• Fiber optic plate
• CMOS imaging device

Incident X-ray photons are converted to visible light by the scintillator and transmitted through the fiber optic plate to the CMOS detector. Image data are transmitted to a host computer through a direct USB connection.

The sensor is portable and is positioned intraorally using standard dental positioning techniques. During clinical use, the sensor is covered with a single-use protective barrier sheath. The sheath is a separate device.

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