MeVis Liver Suite
MeVis Medical Solutions AGMeVis Liver Suite is a medical image analysis software designed to assist physicians, especially radiologists and surgeons, in evaluating the liver and its vascular anatomy using CT and MR images. It provides tools for manual and AI-based semi-automatic segmentation of abdominal organs, liver lesions, and vascular structures, supporting treatment planning and follow-up assessment for liver-related conditions. The software calculates volumes, visualizes 3D vascular tumor margins, and enables manual spatial registration of images, enhancing clinical workflow without replacing diagnostic workstations.
Intended Use
MeVis Liver Suite is an image analysis software intended for visualization and evaluation of hepatic imaging derived from CT and MR scans, supporting treatment planning, surgical evaluation, and therapy follow-up of liver and related vascular anatomy.
Technology
The software supports manual segmentation and 3D visualization of abdominal organs, liver-related vascular structures, and lesions from CT and MR images. It includes AI-based semi-automatic pre-segmentation of liver and vascular structures for CT scans of healthy living liver donors, and calculates volumes, vascular tumor margins, and liver volume to body weight ratios. Images can be manually registered across phases and modalities.
Performance
Performance testing included validation of AI pre-segmentation quality on retrospective multi-center data showing dice scores > 85% and Hausdorff distances < 2.0 mm, comparable to predicate devices. Expert clinical scoring showed >80% acceptable accuracy. Volume calculation accuracy and precision were validated with phantoms and clinical data. No new clinical trials were reported.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/10/2023
3 months - 2
FDA Approval
10/27/2023
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