HEPATIC VCAR
GE MEDICAL SYSTEMS SCSHepatic VCAR is a software tool that analyzes CT scans of the liver to help clinicians visualize liver anatomy, detect and measure liver lesions, and assess liver morphology. It provides initial 3D segmentation and vessel analysis with tools allowing users to adjust and confirm segmentation, assisting in clinical review, archiving, and diagnosis related to liver conditions.
Intended Use
Hepatic VCAR is a CT image analysis software package that allows the analysis and visualization of Liver CT data derived from DICOM 3.0 compliant CT scans. It is intended for assessing liver morphology including liver lesions and their change over time, through automated tools for liver, lobe, segment, and lesion segmentation and measurement. It is intended for use by clinicians to process, review, archive, print, and distribute liver CT studies.
Technology
The software employs the same fundamental scientific technology as its predicate device, Volume Viewer Plus. It uses CT DICOM image data input, with equivalent display, formatting, archiving, and visualization technologies. Hepatic VCAR optimizes segmentation algorithms for liver, lesion, portal vein vessel, and liver lobe segmentation. It also includes a Virtual Scalpel feature for liver partition separation independent of vein segmentation.
Performance
The software underwent extensive quality assurance measures including risk analysis, requirements reviews, design reviews, system verification, bench testing for performance, and verification of safety. Testing did not raise any safety or effectiveness issues for the device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2013
4 months - 2
FDA Approval
4/22/2014
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