FDA-cleared K190017

LiverMultiScan (LMSv3)

Perspectum Diagnostics Ltd

LiverMultiScan LMSv3 is MR diagnostic software for non-invasive liver evaluation from abdominal MR images, including automated liver segmentation and proton-density fat fraction,...

Modality
MRI
Anatomy
Abdomen including liver
Decision
2019-06-27
FDA-cleared K183133

MRCP+ v1.0

Perspectum Diagnostics Ltd

MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation,...

Modality
MRI
Anatomy
Abdomen
Decision
2019-01-09