NIDEK recently announced it has received U.S. Food & Drug Administration 510 K clearance for the Manual Analysis Function for the CEM-530 Specular Microscope. The new clearance allows practitioners to manually analyze cells that are not identified by the auto-analysis function due to poor image quality, according to a press release.
The newly approved Manual Analysis Function is available via a software upgrade for the specular microscope. Center point manual analysis can be initiated by selecting the approximate center of a cell, and adjoining cells are detected based on surrounding points. This can be useful when groups of cells are clumped together.
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NIDEK, a global leader in laser and diagnostic instrumentation for the eye care industry, is pleased to announce that the United States Food & Drug Administration (FDA) has issued 510 K Clearance for the Manual Analysis Function for the CEM-530 Specular Microscope. With FDA clearance, the manual analysis feature is now available in the USA. This feature will enable practitioners to analyze cells manually that are not identified by the auto-analysis function due to poor image quality.
The CEM-530 Specular Microscope can be upgraded to manual analysis function by a software upgrade. The center point manual analysis is initiated by selecting the approximate center of a cell. Adjoining cells are then detected based on the surrounding points. This method is particularly effective for areas where groups of cells are clumped together. The versatility of automated and manual analysis allows speed and precision.