FDA-cleared K173749
AMRA Profiler
AMRA Medical AB
Authorized purpose: AMRA Profiler is MR diagnostic software for non-invasive fat and muscle evaluation, including liver fat fraction, T2 star, and muscle volume measurements from supported DICOM MR datasets.
- Modality
- MRI
- Anatomy
- Body including liver and skeletal muscle
- Decision
- 2018-12-06