(363 days)
Indicated for use as a magnetic resonance diagnostic device software application for non- invasive fat and muscle evaluation that enables the generation, display and review of 2D magnetic resonance medical image data.
Designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the body including the liver. Other physical parameters derived from the images may also be produced.
Provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of fat fraction in the liver, T2* and muscle volume.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
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This document is an FDA 510(k) clearance letter for the AMRA Profiler device. It provides information about the device's indications for use but does not contain any details regarding acceptance criteria, study design, or performance metrics.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a different document, such as the 510(k) summary, a clinical study report, or a performance testing document.
§ 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.