The risks identified in the risk management documentation have been adequately addressed, no new risks have been identified from the literature, and all hazards and other clinically relevant information have been identified appropriately.Warnings and precautions described in the IFU are adequate for risk mitigation measures to support the intended purpose and application of the device.The intended safety claims of the EPIQ System foreseen by the manufacturer during normal conditions of use have been supported by sufficient non-clinical and clinical evidence.