Device Dossier

Camera, fundus

Device Dossier for Camera, fundus (Camera, fundus, Class IIa, sponsor Carl Zeiss). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

ophthalmic camera is intended to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa, as well as manual measurement of the retina. It provides colour, infrared reflectance and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view

TGA Public Summary