(152 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.
Not Found
This FDA 510(k) clearance letter acknowledges the submission of the AMRA Profiler device but does not contain the detailed acceptance criteria, study design, or performance data. It primarily focuses on the regulatory aspects of the device's clearance.
Therefore, I cannot provide the requested information about acceptance criteria or study details based on the provided text. To answer your questions, I would need access to the full 510(k) summary, clinical study reports, or other relevant performance data that typically accompany such submissions to the FDA.
§ 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.