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
Device Timeline
- 1
Submission
11/21/2022
4 months - 2
FDA Approval
3/21/2023
Other devices from GE Medical Systems SCS
- CardIQ Suite2024 • 510K
- Spine Auto Views2023 • 510K
- CardIQ Suite2022 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.