Dental CBCT X-ray System

The Dental CBCT X-ray System (Model: Hasla) is a cone-beam computed tomography device that produces two-dimensional digital x-ray images (panoramic and cephalometric) and three-dimensional images of the dental, oral, and maxillofacial regions for diagnostic support in adult and pediatric patients aged 6 years and older. The device consists of a frame, x-ray generator with tube and collimator, flat-panel detector, and image processing software workstation.

The subject device (Hasla) and predicate device (iDT901X1) are identical in all technical specifications: tube voltage 60–120 kV, tube current 1–20 mA, focal spot size 0.5 mm, FPD detector with CsI material, 200 µm pixel size (binned), scan times of 15 sec (panoramic), 2.3 sec (cephalometric), and 22 sec (CT), and identical FOV options ranging from 50×50 mm to 230×180 mm. Both use the same power supply (50/60 Hz, 110–120 VAC, 3.0 kVA) and dimensional specifications (1300×1272×2365 mm, 233±5 kg).

FDA-recognized standards include IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (radiation protection), IEC 60601-2-63 (dental x-ray equipment), IEC 61223-3-4 and 61223-3-7 (imaging performance acceptance tests), ISO 10993 series (biocompatibility), ISO 14971 (risk management), IEC 62304 (software lifecycle), and 21 CFR 1020.30–33 (diagnostic and CT x-ray performance standards).

The subject device differs from the predicate only in labeling and model nomenclature (trade name changed from 'Dental Cone-beam Computed Tomography' to 'Dental CBCT X-ray System'; model name changed from 'iDT901X1' to 'Hasla'). Because the device design, working principle, software functions, technical specifications, performance characteristics, indications for use, patient population, and user needs remain identical, these cosmetic changes have no impact on safety or efficacy. Prior electrical safety, EMC, and bench-testing results remain valid; no new testing was required.