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The Unicath SP Biplane System is an Angiographic x-ray imaging system designed for those cardiac catheterization procedures requiring two simultaneous images of the heart and/or coronary arteries. Such systems are used to reduce the time necessary for complex adult cardiac catheterization studies, but they are particularly valuable in pediatric cardiology where biplane imaging allows reduced use of contrast material due to the need for fewer injections. This is a great advantage since contrast causes significant discomfort in children and carries with it an increased health risk for them. The System is designed to be operated by professional medical personnel only.

The Unicath SP Biplane System is an Angiographic x-ray imaging system.

This document is a 510(k) clearance letter from the FDA for a medical device called "Unicath SP BI-Plane (models M269 & M289 combined)". It is a regulatory approval document and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based on the given input. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market, but it does not detail the technical performance or supporting studies.

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