Device Dossier

X-ray image interpretive software

Device Dossier for X-ray image interpretive software (X-ray image interpretive software, Class IIb, sponsor Emergo). ARTG record, intended purpose, GMDN…

Intended purpose

ClearRead CT is comprised of computer-assisted reading tools designed to aid the radiologist in the detection and characterization of pulmonary nodules during the review of screening and surveillance (low-dose) CT examinations of the chest on a non-oncological patient population. ClearRead CT requires both lungs to be in the field of view and is not intended for monitoring patients undergoing therapy for lung cancer or limited field of view CT scans. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.

TGA Public Summary