Device Dossier

Automated retinopathy analysis system application software

Device Dossier for Automated retinopathy analysis system application software (Automated retinopathy analysis system application software, Class IIa,…

Intended purpose

The DR Grading software is intended to screen and grade Diabetic Retinopathy (DR) in patients/general population through colour fundus retinal images. The DR Grader is indicated for use by health care providers to automatically detect and grade diabetic retinopathy in patients who have been diagnosed with diabetes and screen those who have not yet been diagnosed with diabetes.

TGA Public Summary