Details
Device typeOphthalmic image clinical assessment support software, professional-only: A software program intended to be used in a clinical setting to display and analyse/process images of the eye, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of an ophthalmic condition. The images are typically acquired by a slit lamp, fundus camera, or via optical coherence tomography. The software is not dedicated to surgical planning or intraoperative use, and does not incorporate adaptive/dynamic machine learning (ML) models.
FDA categoryDiabetic Retinopathy Detection Device
Device ID00860005195619
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information