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Medical Devices / Submissions and Approvals

FDA Clears CT Device’s Image Reconstruction Engine

April 23, 2019

The FDA granted 510(k) clearance for GE Healthcare’s Revolution Apex computed tomography (CT) device, giving the go-ahead for its Deep Learning Image Reconstruction engine.

The upgraded system uses a deep neural network to create CT images that can improve head, cardiovascular and whole body readings for patients of all ages.

The reconstructed CT images offer strong first impressions with high quality sharpness and noise texture, without compromising dose performance.

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