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Dental X-Ray Device, Ai Ray Lite, Ai Ray Pro, Master Ray

It is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dentist or a dental technician for both adult and pediatric patients.

Dental X-Ray Device is a super capacitor-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic-quality X-ray images utilizing either film or digital imaging techniques. The Portable Dental X-ray Device is intended for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable super capacitor to allow for the Portable Dental X-ray Device, where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility.

The subject devices are the same as our previously cleared AI Ray (Predicate-K222569) in indication for use, fundamental scientific technology, operating parameters, etc. The design changes are only related to several physical specifications (shape, size, weight, shell color) and several performance specifications.

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