Device Dossier

Automated retinopathy analysis system application software

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

Intended purpose

The RetInSight Fluid Monitor is a medical device for professional use only, intended to quantify the volumes of pathological fluids in the retina, i.e. intraretinal fluid (IRF), subretinal fluid (SRF) and pigment epithelial detachments (PED), to support therapeutic decisions in the management of nAMD. Results from the RetInSight Fluid Monitor should not be the sole basis for a patient diagnosis or therapeutic decisions. Results generated by the RetInSight Fluid Monitor should be considered along with the assessment of the patient´s history and the current clinical condition of the patient.

TGA Public Summary