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510(k) Data Aggregation
K Number
K051528Device Name
MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE
Manufacturer
MEVIS TECHNOLOGY GMBH & CO. KG
Date Cleared
2005-07-20
(42 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
**MEVIS TECHNOLOGY GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MeVis LiverAnalyzer / LiverViewer Software™ device is intended for preoperative planning in liver surgery. The device is used to analyze data and to display image analysis and risk analysis results for the preoperative planning in liver surgery, e.g. organ segmentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections splitting the liver or to calculate safetymargins around lesions identifying affected vascular branches and vascular territories supplied or drained by these branches.
Device Description
MeVis LiverAnalyser / LiverViewer Software™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format. The MeVis-LiverAnalyser is used to analyze data for preoperative planning in liver surgery. The MeVis-LiverAnalyzer contains dedicated methods for organ segmentation, tumor segmentation, and segmentation of intrahepatic vasculature as well as for the approximation of vascular territories. While using the MeVis-LiverAnalyser a number of masks are produced to merge voxels into sets. Each of this set is meant to represent a specific anatomical entity. All volumes calculated by the MeVis-LiverAnalyzer are given directly by the number of voxels in one of these sets multiplied by the voxel volume. No direct measure of anatomical entities is performed.
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