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510(k) Data Aggregation
K Number
K211983Device Name
AMRA Profiler
Manufacturer
Date Cleared
2021-11-24
(152 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
AMRA Medical AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
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K Number
K173749Device Name
AMRA Profiler
Manufacturer
Date Cleared
2018-12-06
(363 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
AMRA Medical AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
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