FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

Precision DL by GE Healthcare is a deep learning software designed to improve the quality of non-Time-of-Flight PET images used in clinical oncology. It enhances image contrast and reduces noise, helping clinicians obtain clearer PET scans to better detect and evaluate cancer, ultimately supporting improved patient care.

FDA #
K223212
Product Code
KPS

SIGNA Hero is a whole body 3.0 Tesla MRI scanner from GE Healthcare that supports high resolution images with a high signal-to-noise ratio and short scan times. It produces detailed images of structures and functions throughout the body to aid physicians in diagnosis by providing axial, sagittal, coronal and oblique images, along with spectroscopic and dynamic imaging capabilities.

FDA #
K213668
Product Code
LNH

The SIGNA Premier by GE Healthcare is a whole-body magnetic resonance imaging (MRI) system designed to produce high-resolution diagnostic images of many body parts including the head, spine, joints, and heart. It incorporates a new AI-powered software feature called AIR Recon DL that improves image quality by enhancing signal-to-noise ratio and sharpness, while allowing for shorter scan times. This helps clinicians get clearer images faster, supporting better diagnosis and patient care.

FDA #
K193282
Product Code
LNH
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