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RS-3000 Advance OCT system receives 510(k) clearance

The RS-3000 Advance optical coherence tomography system has been cleared by the U.S. Food and Drug Administration, Nidek announced in a press release.

The system, which incorporates a scanning laser ophthalmoscope, is designed to evaluate the retina and choroid. It has a wide area scan of 9 mm × 9 mm, a tracing high-definition function and an automatic registration function that compensates for cyclotorsion during image acquisition, the release said.

The tomographer allows high-speed scanning of 53,000 A-scans per second, as well as two additional higher sensitivity scanning modes with tracing.

It can integrate with most electronic medical record systems with Navis-Ex image filing software.