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

The Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray) is a portable, handheld, super capacitor-operated extraoral X-ray source designed to produce diagnostic-quality X-ray images for dental use. It is indicated for use by dentists or dental technicians on both adult and pediatric patients in dental offices and similar clinical environments.

The subject devices share the same fundamental X-ray tube technology, 70 kV fixed tube voltage, constant potential (DC) waveform, and identical X-ray field size (Φ5.9cm±0.1cm) as the predicate. Differences include varied physical dimensions and weights across the three models, modified exposure time ranges (0.02-2.0 seconds for Lite/Master Ray vs. 0.04-1.0 for predicate), reduced tube current and output power for Lite/Master Ray (2 mA, 140W vs. 3 mA, 210W), and single battery pack instead of dual packs in two models.

Testing followed IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-65, IEC 61223-3-4, ISO 14971, 21 CFR 1020.30 and 1020.31, and FDA guidance on hand-held X-ray equipment radiation safety.

The devices are substantially equivalent because they use identical fundamental X-ray technology, maintain the same tube voltage and field size, and employ the same indications for use and clinical functionality as the predicate K222569. All performance differences (size, weight, battery count, exposure range, tube current, output power) are minor design variations that conform to the same applicable safety and performance standards; testing demonstrated these differences do not raise new safety or effectiveness concerns.