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…

Intended purpose

The SPECTRALIS Platform is a non-contact imaging device for the eye. It is intended to be used in combination with the SPECTRALIS Software for conducting measurements and examinations of the eye for · Fundus reflectance imaging · Fluorescence imaging (fluorescein angiography, indocyanine green angiography) · Autofluorescence imaging · Cross-sectional imaging

TGA Public Summary