Automated retinopathy analysis system application software

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

RQSolutions Medical Devices Distribution Support

Class:

Class IIa

Manufactured by:

Thirona BV Toernooiveld 300, Nijmegen, 6525 EC Netherlands

Therapeutic area:

58713 - Automated retinopathy analysis system application software

Therapeutic indications:

The medical device is a software product that analyses an input color fundus image for signs of Age-related Macular Degeneration, Diabetic Retinopathy and glaucoma. The software produces several outputs which includes scores for AMD and DR that are indicative of the severity of AMD and DR; a score for glaucoma that indicates the likelihood of presence of glaucoma; and heat maps indicating possible abnormal areas. Taking the outputs of RetCAD into account, the intended user can decide if the patient should be referred for additional testing.

Authorization status:

A

Authorization date:

2020-06-10