FDA approves new OCT system

Nidek’s RS-3000 Advance Optical Coherence Tomographer has received 510(k) clearance.

The system incorporates a scanning laser ophthalmoscope and is designed to evaluate the retina and choroid. With a wide area scan of 9 mm × 9 mm, it offers 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.

Nidek says it can integrate with most electronic medical record systems using the Navis-Ex image filing software.