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Home Monitoring Ophthalmic Optical Coherence Tomography (OCT) Imaging Device

Details

Device typeRetinal optical coherence tomography system: An assembly of devices that uses a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement of the retina, the retinal nerve fibre layer (its thickness), and optic disk in order to diagnose and manage retinal diseases. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional images of the retina or three-dimensional (3-D) volume scans. Optical coherence tomography (OCT) is used for visualizing the area/location of retinal-thickness abnormalities, macular holes or oedema, atrophy associated with degenerative diseases, glaucoma, and other retinal pathologies.

FDA categoryHome Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

Device ID07290017803012

Catalog number910-0001

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information

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