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

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