VARIOUS OPHTALMOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Primary DI

08053677040529

Basic UDI-DI Code

805367704DiagnosticAI22

Reference

RRTCPRM000

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

CENTERVUE S.P.A.

iCare RETCAD is a stand-alone medical device software that analyses color fundus retinal images to provide results for clinical decision support relating to Age-related Macular Degeneration, Diabetic Retinopathy and Glaucoma. It utilizes artificial intelligence (AI) algorithm to assess and perform interpretation of diagnostic images acquired by retinal imaging devices. 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 iCare RETCAD into account, the intended user can decide if the patient should be referred for additional testing. iCare RETCAD is a software product intended to be used by a healthcare professional such as an ophthalmologist, optometrist, general practitioner or trained grader. The output of the software should always be interpreted together with the color fundus image and the software should only be used with standard medical imaging data in the form of DICOM files or other standardized image file formats such as JPEG, TIF, PNG or BMP.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).