FDA Radiology AI Devices

The Biograph VK10 is a combined Positron Emission Tomography (PET) and Computed Tomography (CT) scanner that provides fused images of both physiological function and anatomical structure. It assists healthcare providers in detecting, localizing, diagnosing, staging, and restaging various diseases such as cancer, cardiovascular and neurological disorders. The system supports single modality and combined PET/CT imaging and can aid in treatment planning and lung cancer screening in high-risk populations.

The Cartesion Prime (PCD-1000A/3) V10.15 is a PET/CT emission computed tomography system designed for diagnostic imaging. It helps clinicians by producing high-quality fused metabolic and anatomical images through PET and CT scans, improved by AI-driven noise reduction and motion correction. This aids in the evaluation, diagnosis, and treatment planning of various diseases such as cancer, cardiovascular and neurological disorders.

The Biograph Vision.X and Biograph Vision.X Edge are advanced combined PET and CT scanners that provide high-resolution images by fusing metabolic and anatomical information. These systems assist healthcare professionals in detecting, diagnosing, and monitoring diseases such as cancer, cardiovascular and neurological disorders, and support treatment planning and interventional procedures.

The Vereos PET/CT is an advanced diagnostic imaging device that integrates PET and CT technologies to produce detailed anatomical and functional images of the whole body and major organs. It helps clinicians detect, localize, diagnose, and monitor diseases in oncology, cardiology, and neurology with improved image quality by employing an AI-powered adaptive reconstruction algorithm, enhancing diagnostic confidence and treatment planning.

The Biograph Horizon is a medical imaging system that combines positron emission tomography (PET) and computed tomography (CT) to provide detailed metabolic and anatomical images of the body. It helps clinicians in detecting, diagnosing, and monitoring diseases such as cancer, cardiovascular, and neurological disorders by fusing high-resolution functional and anatomical data, thereby improving treatment planning and clinical decision-making.