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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.

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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 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.

Ask a specific question about this device