FDA Radiology AI Devices

The Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is an advanced CT scanner that captures high-resolution 3D images of the whole body. It uses an AI-based algorithm called AiCE (Advanced intelligent Clear-IQ Engine) to reduce image noise and enhance image quality, which helps clinicians detect details more clearly. This makes diagnoses more accurate and can potentially reduce patient radiation exposure.

The Aquilion ONE (TSX-305A/6) V8.9 with AiCE is a whole body multi-slice helical CT scanner designed to acquire high-quality cross-sectional images of the whole body, including the head. It uses an advanced AI-powered reconstruction algorithm called AiCE to reduce image noise and improve image quality, helping clinicians to perform more accurate and detailed imaging across multiple anatomical regions like abdomen, pelvis, lung, and cardiac areas.

Deep Learning Image Reconstruction by GE Medical Systems is a software option for CT scanners that uses a dedicated deep neural network to generate high-quality cross-sectional images of the head and whole body from X-ray transmission data. It improves image quality while maintaining noise performance and spatial resolution, supporting routine clinical workflows for head, whole body, cardiac, and vascular CT scans across all ages.

FFRct by HeartFlow, Inc. is software that analyzes previously acquired coronary CT images to simulate blood flow and pressure in the coronary arteries. It helps clinicians evaluate coronary artery disease by providing a computer-generated physiological assessment using AI-driven computational models from static CT data.

HeartFlow FFRct is a software tool that analyzes previously acquired coronary CT images to simulate coronary blood flow and pressure, aiding clinicians in evaluating coronary artery disease without additional invasive procedures. It provides functional assessment by generating fractional flow reserve values to support clinical decision-making alongside other diagnostic information.