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The Zeta Diagnostic Retinal Imaging System is intended to be used to capture, archive, and display digital images of the eye, particularly the retina obtained through the use of an ophthalmic camera (fundus camera). The Zeta System is an automated imaging device used in conjunction with a fundus camera that requires minimal 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 Zeta System is comprised of a digital imaging camera or cameras, computer hardware, and a software platform intended to be used to store images captured by the fundus camera. Thus the Zeta Diagnostic Retinal Imaging System has the same intended use and indications as the listed predicate devices. The Zeta Diagnostic Retinal Imaging System is intended to be used to capture, archive, recall and display black and white, and color images of the retina captured using an ophthalmic camera during angiography non-invasively.

The Zeta Diagnostic Retinal Imaging System 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 "eyepix" proprietary imaging software and a computer (CPU) monitor, keyboard and mouse. This total system with imaging software provides acquisition and hardware control capabilities used in conjunction with a fundus camera to take digital pictures of the retina which are then transferred via the digital camera and connecting cable to the computer system where they can be viewed, modified, stored or printed. The Zeta system is intended to capture and store images of the fundus, and it is also indicated for use as an ophthalmic camera for individuals where examination of the fundus have been requested for pathologies.