FDA Radiology AI Devices

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 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.

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.

aPROMISE X is a software platform for healthcare professionals and researchers that assists in accepting, transferring, storing, manipulating, quantifying, and reporting digital medical images from PSMA PET/CT scans. It allows users to visualize multiple scans, mark regions of interest, and perform quantitative analysis to help identify suspicious lesions in oncology cases, improving clinical efficiency and consistency.

SubtlePET is an advanced software tool designed to improve the quality of PET medical images by reducing noise. Utilizing deep learning algorithms, it enhances image clarity, aiding radiologists and nuclear medicine physicians in interpreting PET scans more accurately. This software integrates smoothly into existing radiology workflows by receiving, processing, and forwarding DICOM images, supporting multiple radiotracers used in PET imaging.

The Discovery MI Gen2 is a PET/CT imaging system by GE Medical Systems designed to produce detailed attenuation-corrected PET images combined with CT scans. It helps clinicians by providing anatomically localized images of radiopharmaceutical distribution, aiding diagnosis, treatment planning, and monitoring of diseases such as cancer, neurological disorders, and cardiac conditions across various body regions.

aPROMISE is a cloud-based software platform that helps healthcare professionals and researchers manage, review, and analyze PSMA PET/CT medical images. It offers tools to mark and quantify regions of interest, supporting oncology care by providing quantitative analysis and report generation to inform patient management decisions.

HYPER AiR is a software device that enhances PET images by using pre-trained neural networks integrated into the image reconstruction process. It helps radiologists and nuclear medicine physicians by reducing noise and improving image contrast in fluorodeoxyglucose (FDG) PET scans, thereby potentially improving diagnostic confidence.

Cartesion Prime (PCD-1000A/3) V10.8 is a diagnostic imaging system that combines Positron Emission Tomography (PET) and multi-slice Computed Tomography (CT). It provides fused images to help clinicians assess metabolic and functional information for evaluating oncological, cardiovascular, and neurological diseases. The device incorporates an AI algorithm called AiCE-i that improves PET image quality and reduces noise using deep learning methods, facilitating better diagnosis and treatment planning.