# K211983: AMRA Profiler

- Pathway: 510(k) (Traditional)
- Applicant: Amra Medical AB
- Decided: Nov 24, 2021 after 152 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K241925: VitruvianScan (v1.0) (2024), 0 descendants of its own
- K241280: Constellation (CON-001) (2024), 0 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K211983
Methodology: https://510kreport.com/methodology