True Enhance DL
GE Healthcare Japan CorporationTrue Enhance DL is a deep learning-based software from GE Healthcare Japan Corporation that enhances contrast in standard 120 kVp CT images of the body, making details clearer without requiring changes to acquisition parameters. It is intended to assist clinicians by providing improved image contrast to aid diagnosis and is suitable for patients of all ages.
Intended Use
True Enhance DL is a deep learning-based image processing method intended for contrast enhancement of single energy images.
Technology
True Enhance DL utilizes a deep learning algorithm integrated into the Revolution Ascend CT system software to post-process 120 kVp single energy images, improving image contrast without altering acquisition parameters. It offers four models for different contrast phases and estimates monochromatic 50 keV GSI images from standard CT images.
Performance
The device underwent extensive design verification and validation, including software verification, image quality performance evaluations, and a clinical reader study involving four board-certified radiologists who confirmed improved contrast enhancement compared to native images with no new safety concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/17/2023
4 months - 2
FDA Approval
4/11/2024
Other devices from GE Healthcare Japan Corporation
- Deep Learning Image Reconstruction2023 • 510K
- Deep Learning Image Reconstruction2022 • 510K
- Revolution Ascend2022 • 510K
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