CT CoPilot
ZEPMED, LLC.CT CoPilot is an AI-powered software designed for automatic labeling, visualization, and volume measurement of brain structures from CT scans. It helps radiologists by automating the manual process of analyzing brain CT images, providing detailed segmentation and volumetric data to assist in clinical assessments and comparisons across multiple imaging sessions.
Intended Use
CT CoPilot™ is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain to automate identification, labeling, and quantification and to provide automated registration and reformatting of data.
Technology
CT CoPilot automates post-acquisition quantitative analysis of brain CT images by performing automatic reformatting, labeling, segmentation, and volumetric quantification. It uses registration and segmentation methods similar to the predicate NeuroQuant and outputs DICOM formatted images with color-coded graphical overlays of segmented structures. It includes quality control features calculating a measurement index to assess alignment accuracy and error reporting to ensure processing reliability.
Performance
Laboratory testing showed high registration accuracy and segmentation reliability comparable to expert manual segmentation and predicate device NeuroQuant. Testing on 179 scans showed correlation coefficients of 95-99% accuracy for key brain structures. Reproducibility and accuracy testing confirmed safety and effectiveness with no new safety risks identified compared to predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/11/2016
7 months - 2
FDA Approval
12/7/2016
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