Device Dossier

X-ray system, diagnostic, general-purpose, mobile, digital

Device Dossier for X-ray system, diagnostic, general-purpose, mobile, digital (X-ray system, diagnostic, general-purpose, mobile, digital, Class IIb,…

Intended purpose

Intended for use by adequately trained, qualified and authorized healthcare professionals on both adult and pediatric patients, who cannot be transferred to the stationary X-ray system, for taking diagnostic radiographic exposures for the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in prone or supine positions.

TGA Public Summary