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The Panoramic 200T scanning laser ophthalmoscope is intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

The Optos P200T is a scanning laser ophthalmoscope that uses lasers as a light source that is scanned by a deflection system in two axes across the retina to generate an image. The returned light then travels back along the same path to a light detector that converts the light to an electrical signal. This electrical signal is digitized and used to build up an electronic picture in a computer and displayed either on a cathode ray tube or a liquid crystal display.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The provided text is a 510(k) summary for the Optos P200T Ophthalmoscope, outlining its intended use, principles of operation, modifications from a predicate device (P200CAF), and a determination of substantial equivalence by the FDA.

Specifically, the document focuses on justifying that the P200T is substantially equivalent to its predicate device, the Panoramic 200CAF (K100644), based on similar intended use, indications for use, principles of operation, technological characteristics, and that its minor technological differences do not raise new questions of safety and effectiveness.

Therefore, I cannot provide the requested information.

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