Device Dossier

Spectral-domain optical coherence tomography system

Device Dossier for Spectral-domain optical coherence tomography system (Spectral-domain optical coherence tomography system, Class IIa, sponsor Optimed).…

Intended purpose

A device aiding in the diagnosis and evaluation of posterior and anterior conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis. The device has tomography,biometry,topographical abilities.

TGA Public Summary