Perspectum radiology AI products

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FDA-cleared K213960

LiverMultiScan v5 (LMSv5)

Perspectum

Authorized purpose: LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.LMSv5 is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MRSystems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.LMSv5 provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1(cT1) measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

Modality: MRI
Anatomy: Liver
Decision: 2022-09-06

Oncology quantification Quantification and segmentation