NIDEK RS-3000 Advance Optical Coherence Tomographer Receives 510K Clearance

Fremont, California (EastBayDaily) — NIDEK, Inc., a global leader in the design, manufacturing, and distribution of ophthalmic equipment, is pleased to announce FDA clearance of the RS-3000 Advance. This premier OCT system incorporating Scanning Laser Ophthalmoscope is designed for comprehensive evaluation of the retina and choroid. The RS-3000 Advance provides exquisite detail of the retinal and choroidal microstructures to assist in clinical diagnosis.

Features include the choroidal mode, which allows detailed evaluation of the choroid. A wide area scan of 9 mm x 9 mm ensures excellent overall coverage of the retinal structures. Microsaccades and other involuntary eye movements are compensated by the Tracing HD function during the macular line scans. This function ensures accurate alignment of up to 120 macular line scan images for enhanced image averaging. The automatic registration function compensates for cyclotorsion during image acquisition enhancing the quality of follow-up data.

High speed scanning of 53,000 A-scans/sec during acquisition with tracing increases accuracy as well as two additional higher sensitivity scanning modes with tracing that may enable imaging through media opacities.

The RS-3000 Advance can seamlessly integrate with most EMR systems using the NAVIS-EX image filing software, which networks the RS-3000 Advance and other NIDEK imaging devices.

Mr. Motoki Ozawa, President of NIDEK stated, “We are pleased to have this clearance, and confident the results reflect the quality of our diagnostic tools in imaging that assist doctors in diagnosing ocular diseases.”

About NIDEK:

Founded in Gamagori, Japan in 1971, NIDEK continues to be a global leader in research and development, design, manufacture and distribution of ophthalmic equipment. The United States subsidiary based in Silicon Valley, California, provides sales and service for ophthalmic lasers, refractive lasers, and many advanced diagnostic devices.


Michelle Turner


Karen Rogers