FlightPlan for Embolization
GE Medical Systems SCSFlightPlan for Embolization by GE Medical Systems SCS is a software application that processes 3D X-ray angiography images to help clinicians visualize blood vessels during the planning phase of embolization procedures. It uses AI-powered algorithms to automatically segment vasculature and define root points, assisting physicians in better treatment planning. This enhances clinical decision-making but is not intended for use during the delivery of therapy itself.
Intended Use
FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize vasculature during the planning phase of embolization procedures.
Technology
Software-only application using 3D X-ray angiography (CBCT) images, operating on GE Healthcare interventional X-ray systems and workstation platforms. Includes AI segmentation option based on deep-learning algorithms for automatic vessel extraction and root point definition, validated on contrast-enhanced CBCT scans.
Performance
The software underwent design control testing, verification, and validation per quality system regulations. Bench testing on a segregated set of 207 contrast-injected CBCT scans showed 93.7% success for automatic vessel extraction and 95.2% success for automatic root point definition, exceeding acceptance criteria of 90%. Clinical assessment by interventional radiologists confirmed its utility in planning embolization procedures.
Predicate Devices
No predicate devices specified
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