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FDA-cleared K253413

LiverMultiScan (v6.0)

Perspectum, Ltd.

Authorized purpose: LiverMultiScan v6.0 is MR diagnostic software for non-invasive liver-health assessment that generates, displays, and supports review of MR data and quantitative cT1, PDFF, and LIC metrics or composite images for trained healthcare-professional interpretation.

Modality
MRI
Anatomy
Liver
Decision
2026-03-09
FDA-cleared K203280

Hepatica v1 (Hepatica v1.0.0)

Perspectum Ltd.

Authorized purpose: Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health. Hepatica (Hepatica v1) uses image visualization and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrics present numerical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health. Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of patient's liver on a segmental basis. It is not intended to replace the established procedures for the assessment of patient's liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica (Hepatica v1), may support surgical decision making.

Modality
MRI
Anatomy
Liver
Decision
2021-01-12
FDA-cleared K202170

LiverMultiScan

Perspectum LTD

Authorized purpose: LiverMultiScan LMSv4 processes abdominal MRI, including liver images, to generate pixel maps and measurements for proton-density fat fraction, T2 star, and corrected T1, with automated liver segmentation and region-of-interest tools for trained clinician interpretation.

Modality
MRI
Anatomy
Abdomen including liver
Decision
2020-10-02