FDA Product Code OBO: Tomography, Optical Coherence

Optical coherence tomography provides microscopic-resolution imaging of ocular structures. FDA product code OBO covers OCT systems used in ophthalmology for retinal and anterior segment imaging.

These devices use near-infrared light interference to generate cross-sectional images of the retina, optic nerve, and anterior chamber at near-histological resolution. OCT has transformed the diagnosis and management of macular degeneration, glaucoma, and diabetic retinopathy.

OBO devices are Class II medical devices, regulated under 21 CFR 886.1570 and reviewed by the FDA Ophthalmic panel.

Leading manufacturers include Heidelberg Engineering GmbH, Topcon Corporation and Carl Zeiss Meditec, Inc..