Hepatic VCAR
GE Medical Systems SCSHepatic VCAR is a medical software designed to assist clinicians in analyzing liver CT scans by providing automated and editable 3D segmentation of the liver, liver lesions, and hepatic artery. It uses deep learning algorithms to improve accuracy, helping to assess liver morphology and changes over time, thereby facilitating faster and more precise liver evaluations.
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, designed for assessing liver morphology including lesions and their changes over time using automated tools for segmentation and measurement. Intended for clinicians to process, review, archive, print and distribute liver CT studies.
Technology
Hepatic VCAR uses two deep learning convolutional neural networks to segment the liver contour and hepatic artery on CT exams. This replaces traditional deterministic and manual methods from the predicate device, allowing semi-automatic segmentation and interactive editing by the user.
Performance
Performance testing demonstrated that the new deep learning algorithms met design inputs and user needs without unexpected risks. Bench tests showed agreement with expert-annotated ground truth. Clinical assessment by three board-certified radiologists confirmed segmentation capabilities.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2019
3 months - 2
FDA Approval
3/20/2020
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