FDA Radiology AI Devices

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.

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.

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.

HYPER DLR is a software-only device that applies a pre-trained convolutional neural network to reduce noise in fluorodeoxyglucose (FDG) PET images. It improves image quality by distinguishing and removing noise components while preserving image details, aiding radiologists and nuclear medicine physicians in better image interpretation.

The Biograph Vision and Biograph mCT PET/CT systems from Siemens are advanced imaging machines that combine CT and PET technologies to produce high-resolution images showing both anatomical structures and physiological functions. These systems help healthcare professionals detect, localize, diagnose, and stage various diseases including cancer, cardiovascular, and neurological disorders, and also assist with radiotherapy and interventional procedures.

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.

SubtlePET is a software product that uses deep neural network-based AI algorithms to reduce noise and enhance the structural quality of PET images, including PET/CT and PET/MRI scans. It integrates into existing clinical workflows by acting as a DICOM node to process and forward enhanced images, helping radiologists and nuclear medicine physicians better visualize and analyze PET scans for improved diagnostic confidence.