# K232045: MeVis Liver Suite

- Pathway: 510(k) (Traditional)
- Applicant: MeVis Medical Solutions AG
- Decided: Oct 27, 2023 after 109 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954874 (1996). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133643: Syngo, CT Liver Analysis, Siemens Medi Cal Solutions, Inc. (2014) Summary page 6.
- K173420: Radiomics App v1.0, Microsoft Corp. (2017) Summary page 6.

## Indications for use
MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM). MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver and liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or therapy follow-up assessment of the hepatic system and related vascular structures. MeVis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRI, and MRCP. MeVis Liver Suite only allows import of homogenous image series (i.e., image and pixel size must be constant within each series) and with orthogonal image matrix (without a gantry tilt). Images with a resolution of > 5mm slice spacing are not suitable for image analysis with MeVis Liver Suite. MeVis Liver Suite can be used for manual segmentation, user-defined manual labeling, and 3D visualization of: - abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, and pancreas) - liver related vascular structures (i.e., bile ducts, hepatic artery, hepatic vein, portal vein, and inferior vena cava) - lesions inside and adjacent to the liver The tools for manual segmentation and 3D visualization are applicable for CT and MR imaging studies. In addition to the manual segmentation tools, MeVis Liver Suite provides AI based semi-automatic pre-segmentation tools for liver, hepatic artery, hepatic vein, and portal vein restricted to CT scans of potential living liver donors with healthy livers and intended for: - Liver: contrast enhanced late-venous and venous phase - Hepatic vein: contrast enhanced late-venous and venous phase - Portal vein: contrast enhanced late-venous and venous phase - Hepatic artery: contrast enhanced arterial phase Using MeVis Liver Suite, users can evaluate the segmented objects by exploring, calculating, and manually correcting: - the volume of the segmented abdominal organs (see above) - the volume of the segmented lesions inside and adjacent to the liver - the volume of the manually defined parts of the liver - by defining separation planes (“separation proposals”) - from vascular territories that are derived from the user-defined labeling of the liver related vascular structures - 3D visualizations of user-defined (vascular) tumor margins (coloring of area - based on user-defined margin sizes/distances - between the edges of user-defined lesions in relation to the edges of user-defined vascular structures of the liver) - based on user provided values, calculation of liver volume to body weight ratios (i.e., estimated weight for remnant or graft, body surface area, graft to recipient body weight ratio, graft to SLV ratio, remnant to body weight ratio). Using a manual spatial registration of the images, the segmented objects (created on different CT phases and MRI sequences) can be visualized together. The information created with MeVis Liver Suite is intended to be used only in addition to the original images, clinical data, and the real anatomical and clinical situation. Physicians make all final patient management, assessment, and treatment decisions. MeVis Liver Suite is not intended for the anatomical systems integumentary, skeletal, muscular, lymphatic, respiratory, nervous, reproductive, and cardiovascular (excluding hepatic). MeVis Liver Suite does not support the following application areas: real time viewing, diagnostic review, image manipulation, optimization, virtual colonoscopy, and automatic lesion detection. MeVis Liver Suite does not utilize high-resolution displays or display drivers and should not be used as a replacement for a PACS workstation. Intended Patient Population: The intended patients for MeVis Liver Suite are oncologic patients or hepatic donor/transplant patients. CT or MR imaging with contrast agents need to be possible for analysis of vascular structures inside the liver. The age group for the intended patient population is 18 or older. In addition, the semi-automatic pre-segmentation tools are restricted to CT scans of potential living liver donors with healthy livers. Intended Part of the Body: Images supported for the intended medical indication include the abdominal body part with the liver and related vascular structures (bile ducts, hepatic artery, hepatic vein, portal vein, inferior vena cava). Intended User Profile: The intended users are radiologists and surgeons. Intended Use Environment: The use environment is expected to be in an office environment under typical office conditions in hospitals or medical practices. Operation Principle: The software acts as modality for display of CT or MR imaging data, and for visualization of the image analysis results on a computer system. MeVis Liver Suite does not come into direct contact or indirect contact with patients or other medical devices.

Source page: https://510kreport.com/device/K232045
Methodology: https://510kreport.com/methodology