Dental X-RAY Unit (AJX200)

The Dental X-RAY Unit (AJX200) is an extraoral dental X-ray system that emits X-rays to produce diagnostic images of human teeth. The X-rays are recorded on intraoral dental X-ray film or digital image receptors. It is intended for use in dental hospitals or general hospitals with dental offices and is suitable for both adult and pediatric patients.

The device is wall-mounted (versus the predicate's handheld design) and powered by single-phase AC 100-240V converted to DC, compared to the predicate's rechargeable battery. Key specifications match: 200mm source-to-skin distance, 65kV tube voltage, 2.5mA tube current, constant potential (DC) waveform, and adjustable exposure time (0.02–2.00s). Both use X-ray tubes and similar user interfaces with jog dial and preset selections.

IEC 60601-1:2005 (general electrical safety), IEC 60601-1-3:2008 (radiation protection), IEC 60601-2-28:2017 (X-ray tube assemblies), IEC 60601-2-65:2012 (dental intraoral X-ray equipment), IEC 60601-1-2:2014 (electromagnetic compatibility), and IEC 60601-1-6:2010 (usability). Software verification and validation testing were conducted per FDA 2023 guidance.

The AJX200 is substantially equivalent to the predicate (EzRay Air Portable VEX-P300) because they share the same intended use (diagnostic dental radiography), principle of use (X-ray tube), key performance parameters (source-to-skin distance, tube voltage, current), and field size. Minor differences (wall-mounted vs. handheld, AC vs. battery power, exposure time ranges) do not raise new safety or effectiveness issues and are related to design choices rather than fundamental function.