GE HealthCare Submits 510(k) for CleaRecon DL Technology

GE HealthCare has submitted its 510(k) application to the U.S. Food and Drug Administration for CleaRecon DL, an AI-driven deep learning technology aimed at enhancing the quality of cone-beam computed tomography (CBCT) images in the interventional suite. The technology, which is pending clearance, will be showcased at the Radiological Society of North America’s (RSNA) 2024 Annual Meeting. Designed to be integrated into Allia Image-Guided Solutions (IGS) Systems, CleaRecon DL uses AI-based reconstruction to remove streaks from CBCT images without introducing additional artifacts. This technology aims to improve image clarity, facilitating more accurate analyses and accelerating the adoption of CBCT in daily clinical practice.

With more than two decades of leadership in CBCT innovation, GE HealthCare continues to push the boundaries of interventional imaging. CleaRecon DL addresses key challenges in obtaining high-quality CBCT images, such as artifacts caused by patient movement and contrast distribution. GE Healthcare is also launching OnWatch Predict, a predictive monitoring solution designed to enhance system reliability and reduce unplanned downtime. Through these innovations, the company is helping clinicians achieve better clinical outcomes while improving operational efficiency, further advancing its mission to transform healthcare delivery and improve patient care worldwide.

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