Deep Learning Image Reconstruction
GE Healthcare Japan CorporationDeep Learning Image Reconstruction software by GE Healthcare is an AI-powered CT image reconstruction tool that uses a deep neural network to produce high-quality CT images for head, whole body, cardiac, and vascular scans. It improves image noise, contrast detectability, and spatial resolution, helping clinicians obtain clearer images from CT scans for accurate diagnosis and patient care.
Intended Use
The Deep Learning Image Reconstruction software is intended for head, whole body, cardiac, and vascular CT scans.
Technology
Uses a dedicated Deep Neural Network (DNN) trained to generate CT images, integrated into existing raw data-based reconstruction chain on GE's Edison Platform, producing DICOM compatible TrueFidelityTM CT images. Provides user-selectable reconstruction strengths (Low, Medium, High).
Performance
Performance validated through extensive bench testing and a clinical reader study with 60 cases. Bench testing assessed low contrast detectability, image noise, spatial resolution, artifact suppression, and pediatric imaging. Clinical study involved 7 radiologists evaluating image quality metrics with comparisons to a predicate device, demonstrating equivalence in safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/15/2019
28 days - 2
FDA Approval
12/13/2019
Other devices from GE Healthcare Japan Corporation
- True Enhance DL2024 • 510K
- Deep Learning Image Reconstruction2023 • 510K
- Deep Learning Image Reconstruction2022 • 510K
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