(274 days)
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.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.