FDA Radiology AI Devices

The Biograph Vision and Biograph mCT PET/CT systems by Siemens are advanced imaging devices combining positron emission tomography (PET) and computed tomography (CT). These systems help clinicians detect and diagnose various conditions by providing detailed molecular and anatomical images, facilitating better patient management.

The uMI Panorama is a combined PET/CT diagnostic imaging system designed to assist healthcare professionals in detecting and evaluating diseases like cancer, heart, and neurological disorders. It fuses PET metabolic functional imaging and CT anatomical imaging with advanced AI algorithms to improve image quality, reduce artifacts, and enhance diagnostic confidence. It supports PET/CT and single modality CT imaging, including low dose CT lung cancer screening, providing comprehensive information for patient management.

The uMI Panvivo is a combined PET/CT imaging system designed to provide high-quality functional and anatomical images to help clinicians detect, localize, evaluate, and monitor abnormalities such as tumors, lesions, infections, and other conditions across various body areas. It supports better patient experience with a large bore and advanced iterative reconstruction algorithms aided by deep learning, improving image quality and diagnostic accuracy. Additionally, it assists in radiotherapy planning and interventional radiology procedures.

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 uMI Panorama is a diagnostic imaging system combining PET and CT scans to provide both functional and anatomical information of the body. It helps healthcare professionals detect and evaluate diseases in oncology, cardiology, and neurology by offering fused metabolic and anatomical images. The device includes AI-based software updates to improve image reconstruction and analysis, enhancing diagnostic accuracy and patient management.

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 uMI Panorama is a PET/CT system that provides combined metabolic and anatomical imaging to assist healthcare professionals in detecting, diagnosing, staging, and managing various diseases including oncology, cardiology, and neurology conditions. It supports both PET and standalone CT imaging and can be used for low dose CT lung cancer screening, enhancing patient care with fused functional and anatomical images.

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.

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.

The uMI Panorama is a diagnostic imaging system that combines PET and CT imaging modalities to provide detailed metabolic and anatomical information. It assists clinicians in detecting, diagnosing, staging, and managing diseases, inflammation, infection, and disorders in multiple clinical fields. This system can also independently function as a CT scanner for lung cancer screening and delivers enhanced image reconstruction through AI algorithms, improving image quality and diagnostic accuracy.