x-ray systems diagnostic computed tomography full body and application systems

Product Name: ARTG No: 93235, 93337, 95570, 95769, 96044, 96193, 97830, 98358, 98865, 98868, 116979, 119817, 133024
Country: Australia (AU)

Medical Services Advisory Committee

Outcome Measure

a. Safety: Primary – Adverse events: Physical, psychological due to testing (anxiety to a false positive diagnosis), delay from false negative diagnosis Secondary – Exposure to radiation (p. 35)<br>b. Efficacy: Diagnostic accuracy (sensitivity and specificity (rates of false positives and negatives), likelihood ratios and diagnostic odds ratios, positive and negative predictive values, diagnostic yield) (p. 49), change in management (treatment rates, method of treatment, time to diagnosis, rate of referral to specialist, rates of diagnostic tests,change in health outcomes: Primary – rate of survival/death, symptom resolution, quality of life, functional status, acute myocardial infarction, Secondary – Hospital length of stay, discharge diagnosis, rate of readmission (p. 97)

Body Classification

Blood, Heart and Circulation

Device Type

Diagnostic imaging device

Device Category


Risk Classification



coronary arthery disease, cardiomyopathy, coronary arthery anomalies and fistula


I25.1, I42