FlightPlan for Liver
GE Medical Systems SCSFlightPlan for Liver is a post-processing software that helps physicians analyze 3D X-ray angiography images to visualize the liver's vasculature and identify arteries near hypervascular lesions. It incorporates AI algorithms, including deep learning-based liver segmentation, to support the planning of liver embolization procedures, improving physician workflow and precision in treatment planning.
Intended Use
FlightPlan for Liver is a post processing software package that helps the analysis of 3D X-ray angiography images of the liver. Its output is intended as an adjunct means to help visualize vasculature and identify arteries leading to the vicinity of hypervascular lesions in the liver.
Technology
The software operates on GE's Advantage Workstation and AW Server platforms, using multi-modality 3D review and semi-automatic vessel segmentation algorithms. It includes new AI-based features: a deep learning-based Liver Segmentation algorithm for automatic liver segmentation and a Virtual Parenchyma Visualization algorithm to display distal liver regions adjacent to vessels. It allows vessel vicinity analysis, live tracking of vessels, and export of results for 3D roadmapping.
Performance
The device underwent design control testing per GE's quality system including verification, validation, and system testing. Engineering bench testing demonstrated the new AI algorithms' effectiveness. Clinical testing with 3D X-ray angiography image pairs from France and the USA showed the device met acceptance criteria and aided visualization and analysis of hepatic vasculature for embolization planning without new safety concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/17/2021
7 months - 2
FDA Approval
10/22/2021
Other devices from GE Medical Systems SCS
- CardIQ Suite2024 • 510K
- Spine Auto Views2023 • 510K
- FlightPlan for Embolization2023 • 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.