Diagnostic X-Ray Equipment Model POCT22

The Diagnostic X-Ray Equipment Model POCT22 is a portable dental x-ray system designed for extraoral imaging using intraoral receptors. It is intended for use by trained dentists and dental technicians to produce diagnostic x-ray images for examination and diagnosis of teeth, jaw, and oral structures in both adult and pediatric patients.

The subject device is substantially similar to its predicate (Ray98(P)) in all critical specifications: 70 kVp, 2 mA, 0.4 mm focal spot, 1.5 mm Al filtration, constant potential DC waveform, and identical exposure time ranges (0.04–2.0 seconds). Both have 20.5 cm source-to-skin distance and 6.0 cm cone diameter. The main difference is physical size (subject: 97×247×130 mm vs. predicate: 146×152×241 mm), which does not affect safety or effectiveness.

Testing was performed to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304, IEC 62366, and ISO 14971. Electrical safety and EMC testing were conducted by KCTL, Inc. Laboratories in Korea. Device labeling conforms to 21 CFR 1020.30 and 21 CFR 1020.31.

The subject device has the same indications for use, intended use, and similar technological characteristics as the predicate Ray98(P), with identical electrical and radiological parameters. Both devices underwent the same IEC and ISO standardized testing with conformity established. The minor differences in physical size do not raise new safety or effectiveness concerns. Therefore, the subject device is at least as safe and effective as the predicate and warrants a substantial equivalence determination.