Portable Dental X-ray Device (GT-1)

The Portable Dental X-ray Device (GT-1) is an extraoral X-ray source system intended for use by dental professionals to produce radiographic images of teeth using intraoral image receptors for clinical diagnostic purposes. It is a high-frequency dental X-ray equipment with a rated tube voltage of 65 kV DC and tube current of 2.5 mA, powered by a rechargeable 14.4V DC battery pack.

The GT-1 has dimensions of 13.9" × 4.58" × 10.5", a source-to-skin distance of 21.4 cm (compared to predicate's 20 cm), and a cone diameter of 5.4 cm (vs. predicate's 5.7 cm). It features exposure times of 0.04–2.0 seconds in 0.01–0.40 s increments, constant potential (DC) waveform, total filtration of 1.75 mm Al, and a smaller backscatter radiation shield (154.5 mm diameter, 8 mm thick) than the predicate.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304, IEC 62366, ISO 14971, and 21 CFR 1020.30/1020.31 for electronic product radiation control. Testing included software V&V per FDA guidance (June 2023), clinical image comparison study with six patients, and bench testing measuring MTF, NNPS, and DQE using IEC 62220-1-1 geometry.

The GT-1 is substantially equivalent to the HyperLight Portable X-ray Unit (K232068) predicate because both devices share identical intended use (extraoral X-ray source for intraoral imaging), same regulatory classification (Class II extraoral source X-ray system), and equivalent electrical and performance specifications (65 kVp, 2.5 mA, constant potential DC). Minor design differences (slightly larger source-to-skin distance, smaller cone diameter, lighter scatter shield) do not affect safety or effectiveness and may provide improvements. Clinical testing demonstrated comparable image quality, and bench testing confirmed adequate imaging performance metrics.