NIDEK's CEM-530 Specular Microscope received 510K clearance
- February 10, 2014, Gamagori, JAPAN -
NIDEK, a global leader in the design, manufacturing, and distribution of ophthalmic equipment, announces that the United States Food & Drug Administration (FDA) has issued 510K clearance for its' revolutionary new CEM-530 Specular Microscope that acquires images of the corneal endothelium and provides analysis very quickly and easily. The auto tracking capabilities make acquisition speedy and straightforward.
Features include paracentral specular microscopy as well as peripheral images, two-second auto analysis, automatic indication of the optimal image, 3-D auto tracking, auto shot, and a tiltable touch screen with built-in printer.
The paracentral images are captured at eight points, at a 5° visual angle within a 0.25 mm x 0.55 mm field and enable enhanced assessment surrounding the central image.
Sixteen images are captured and automatically sorted based on quality. Once the best image is selected, complete analysis is automatically performed in two seconds with the CEM-530. The analysis screen allows visualization of the endothelial cells in four modes: trace, photo, area, and apex. This feature enables the clinician to verify analysis values with the corresponding cell images. The 3-D auto tracking, auto shot, and tiltable touch screen provide ease of use, allowing faster and more accurate measurement. An LED light source is utilized for flash, which reduces power consumption, lasts longer, and saves on operational costs.
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 corneal referencing and early diagnosis of endothelial disease."