FREMONT, Calif., April 23 -- Nidek Inc. said the US Food and Drug Administration has granted 510(k) clearance for Nidek's NM-1000 Digital Non-Mydriatic Fundus Camera. The Nidek NM-1000 can now be marketed and sold for use in capturing images of the retina and the anterior segment of the eye.
The camera provides high-resolution megapixel 45-degree images by incorporating a digital progressive-scan CCD camera. The 6.4-inch color LCD display and control panel allow ease of operation for image capture, editing and transmission of image data to a removable ATA flash card. The image data can also be transmitted via USB, RGB or NTSC signal outputs to other devices, such as the Nidek Advanced Vision Information System.