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The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners. The coil is intended to facilitate complete MR imaging of the intracranial/extracranial neurovasculature and skull base.

The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil and is indicated for use only under the supervision of a physician or certified MR technologist who is trained in the field of Diagnostic Resonance Imaging.

The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners.

This document describes a 510(k) premarket notification for an MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the Medrad 1.5 Tesla 8-Receiver Neurovascular Coil (K023596).

This submission does not contain information about acceptance criteria or a study proving device performance against such criteria for a software or AI/ML-driven device. The provided text is for a hardware medical device (an MRI coil) and primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison of features and intended use.

Therefore, I cannot extract the requested information in the format provided in your prompt, as it is designed for studies validating AI/ML diagnostic tools. The information available in the document is suitable for a hardware device submission focused on substantial equivalence.

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