Nidek ophthalmic OCT system receives FDA clearance

Ophthalmic equipment developer, maker, and distributor Nidek (Fremont, CA) has received FDA approval for the company's RS-3000 Advance optical coherence tomography (OCT) system, which incorporates a scanning laser ophthalmoscope to evaluate the retina and choroid. The system provides detail of the retinal and choroidal microstructures to assist in clinical diagnosis.

Related: PRODUCT FOCUS: OCT systems for ophthalmology

Features include a choroidal mode that allows detailed evaluation of the choroid. A wide area scan of 9 × 9 mm ensures overall coverage of retinal structures. Microsaccades and other involuntary eye movements are compensated by the Tracing HD function during macular line scans, ensuring accurate alignment of up to 120 macular line scan images for enhanced image averaging. An automatic registration function compensates for cyclotorsion during image acquisition. The system also offers high-speed scanning of 53,000 A-scans/s during acquisition with tracing, as well as two additional higher sensitivity scanning modes with tracing to enable imaging through media opacities.

The system integrates with most electronic medical record (EMR) systems using the company's NAVIS-EX image filing software, which networks the system and other Nidek imaging devices.


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