Radiology · 510(k) · 2018
AMRA Profiler
AMRA Medical AB. Cleared by FDA on 6 December 2018 under submission K173749, product code LNH (system, nuclear magnetic resonance imaging). What FDA's record says, in FDA's words.
Device record · K173749
- Device. AMRA ProfilerDEVICE
- Company. AMRA Medical AB (SE)COMPANY
- Decision. 6 December 2018, 510(k), substantially equivalent (traditional review); received 8 December 2017DECISION
- Panel. RadiologyPANEL
- Product code. LNH, System, Nuclear Magnetic Resonance ImagingCODE
- Regulation. 21 CFR 892.1000, Class IIREG
- Source. FDA database entry · decision document (3 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedMRI
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4,787 reports filed against devices carrying product code LNH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
29 September 2026 · Malfunction · Achieva 1.5T Dstream · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000174
28 September 2026 · Malfunction · Achieva 1.5T · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000166
Philips received a report that the Quadrature Body Coil (QBC) seal on the front cover is coming loose. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is loose, it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000167
Philips received a report that the upper Quadrature Body Coil (QBC) seal has peeling off. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is peeled it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000168
Philips received a report that the Quadrature Body Coil (QBC) seal has come loose. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal comes loose it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000169
Philips received a report that the upper Quadrature Body Coil (QBC) seal has come loose This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is loose it is likely that this could lead to serious injury.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code LNH, in Radiology, or cleared in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.