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The OPTO Global Digital Fundus Camera System Model ADS 1.5 is intended to be used to capture, archive, recall and display black and white, and color images of the retina, as well as surrounding areas, to aid in the diagnosis and monitoring of diseases of the eye that may be viewed and photographed non-invasively.

The OPTO Global ADS 1.5 Digital Fundus Camera System is an automated imaging device used in conjunction with a digital camera that requires ninimal intervention during the capture of an image. The system is simple to use and requires minimal training for a user to become proficient with the system. Like the listed predicate devices, the Opto Global Digital Fundus Camera System Model ADS 1.5 is comprised of a digital imaging camera, computer hardware, and a software platform intended to be used to store images captured by the fundus camera. The Opto Global Digital Fundus Camera System Model ADS 1.5 is comprised of the following components: A digital sensor head (digital camera) a computer interface circuit board (digital image capture card), and connecting cables. These components are then combined and sold together with our "OPTO Global Capture" proprietary imaging software and a computer (CPU) monitor, keyboard and mouse. This total system with imaging software provides acquisition and hardware control capabilities used to take digital pictures of the retina which are then transferred via the digital camera and connecting cable to the computer system transment can be viewed, modified, stored or printed.