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The Coronis 5MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

The Coronis 5MP device is a digital image display system. The Barco Coronis 5MP device consists of components to provide high resolution visualization of digital images.

This document is a 510(k) summary for the Barco Coronis 5MP Medical Flat Panel Display System, a digital image display system. As such, it is a notification of intent to market and not a study proving the device meets acceptance criteria. The document explicitly states:

"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..."

This means the FDA has determined the device is substantially equivalent to a previously cleared device (Barco NV Display Systems Coronis 3MP Medical Flat Panel Display System (K013922)) based on its intended use and technological characteristics, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets them. It is a regulatory clearance document based on substantial equivalence.

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