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The Raycast MammoRx Carbon Fibre Breast Board is a positioning and immobilization system to set-up and reproduce the supine position of a breast patient during radiation therapy.

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This document is a 510(k) premarket notification decision letter from the FDA for the "Raycast MammoRx Carbon Fibre Breast Board." It informs the manufacturer that their device has been found substantially equivalent to a predicate device.

This document does not contain information about the acceptance criteria and study results for the device's performance.

The provided text focuses on the regulatory approval process (510(k)), classification of the device, applicable regulations, and administrative details. It includes the device name, its intended use (positioning and immobilization for breast radiation therapy), and the 510(k) number (K162355).

Therefore, I cannot provide the requested information from this document. To answer your query, a different document, such as the actual 510(k) submission or a performance study report, would be necessary.

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