Deep Learning Image Reconstruction
GE Healthcare Japan CorporationDeep Learning Image Reconstruction by GE Healthcare is a software solution that uses a specialized deep neural network to reconstruct high-quality CT images from raw X-ray data. It produces images with less noise and improved image quality while maintaining low radiation dose. It supports head, whole body, cardiac, and vascular CT scans, helping clinicians obtain clearer images for diagnosis.
Intended Use
The Deep Learning Image Reconstruction software is a deep learning based reconstruction method intended to produce cross-sectional images of the head and whole body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Helical (Volumetric), and Cardiac acquisitions, for all ages. Deep Learning Image Reconstruction software can be used for head, whole body, cardiac, and vascular CT applications.
Technology
Deep Learning Image Reconstruction uses a dedicated Deep Neural Network (DNN) designed specifically to generate high quality CT images by integrating deep learning into the scanner's raw data-based image reconstruction chain. The system offers selectable reconstruction strengths (Low, Medium, High) and produces DICOM compatible images called TrueFidelity™ CT Images.
Performance
The software underwent extensive design control, risk analysis, and testing including software unit tests, integration, system testing, image quality bench tests, and simulated use validation. No new hazards or unexpected results were identified. The software demonstrated equivalent or better image quality performance compared to predicate devices and met all design requirements and performance criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/1/2022
3 months - 2
FDA Approval
7/29/2022
Other devices from GE Healthcare Japan Corporation
- True Enhance DL2024 • 510K
- Deep Learning Image Reconstruction2023 • 510K
- Revolution Ascend2022 • 510K
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