3DXR is a post-processing software application by GE Healthcare designed to perform three-dimensional reconstruction of images obtained through 3D acquisition modes of X-ray interventional systems. It incorporates a new Deep-Learning option, CleaRecon DL, to reduce streak artifacts in images, enhancing image clarity to assist physicians in diagnosis, surgical planning, interventional procedures, and treatment follow-up.
Intended Use
3DXR is the AW application which is intended to perform the three-dimensional (3D) reconstruction computation of any images acquired with a 3D Acquisition mode of the X-ray interventional system for visualization under Volume Viewer.
Technology
3DXR is a software-only application running on the Advantage Workstation platform that performs 3D reconstruction of cone-beam CT images from an interventional X-ray system. It includes a new Deep-Learning algorithm (CleaRecon DL) based on a convolutional neural network to remove streak artifacts around contrasted vessels and stents, among other features such as motion artifact reduction and metal artifact reduction.
Performance
Engineering bench tests showed the CleaRecon DL algorithm effectively reduces streak artifacts with significant reduction in mean absolute error and increase in structural similarity index measure. Clinical testing with 110 patient exams across multiple anatomies confirmed improved image clarity in 98% of cases without introducing artificial structures or hiding important anatomical features.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/6/2024
3 months - 2
FDA Approval
2/25/2025
Other devices from GE Medical Systems SCS
- CardIQ Suite2025 • 510K
- VersaViewer2025 • 510K
- CardIQ Suite2024 • 510K
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