Device Dossier

X-ray system, diagnostic, bone absorptiometer, dual-energy

Device Dossier for X-ray system, diagnostic, bone absorptiometer, dual-energy (X-ray system, diagnostic, bone absorptiometer, dual-energy, Class IIb,…

Intended purpose

THE INTENDED USE OF THE DENSITY BONE DENSITOMETER IS THE MEASURE "IN VIVO" OF BONE MINERAL DENSITY IN HUMANS, BOTH ADULTS AND PAEDIATRIC AGE, AND IN SMALL ANIMALS. THE INTENDED USER PROFILE FOR THE DEVICE IS THAT OF A RADIOLOGIST, NUCLEAR MEDICINE DOCTOR, ORTHOPAEDIST, OR A RADIOLOGY TECHNICIAN, NUCLEAR MEDICINE TECHNICIAN, OR A PERSON OF EQUIVALENT CULTURE.

TGA Public Summary