FastStroke, CT Perfusion 4D
GE Medical Systems SCSFastStroke, CT Perfusion 4D is a software package designed to aid clinicians in analyzing and visualizing CT scans, especially for stroke assessment. It processes and displays vascular and perfusion data from CT scans of the head and neck to help identify collateral vessels and perfusion abnormalities, assisting physicians in stroke evaluation and treatment planning.
Intended Use
Assists in the analysis and visualization of CT data from DICOM 3.0 compliant CT scans, displaying head and neck vasculature at different time points of enhancement to aid stroke evaluation.
Technology
The software integrates modified FastStroke and CT Perfusion 4D applications, employs a deep learning convolutional neural network to segment brain ventricles, and provides optimized synchronized display and multiphase colorized vascular views for stroke assessment.
Performance
Bench tests comparing deep learning segmentation results with expert-annotated ground truth showed expected performance. Software validation demonstrated substantial equivalence to predicate devices, with no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2019
11 months - 2
FDA Approval
11/12/2020
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