FDA Radiology AI Devices

The Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system produced by Canon Medical Systems Corporation. It provides high-quality cross-sectional images of anatomical structures in the head or body, including advanced imaging techniques such as non-contrast enhanced MRA and diffusion imaging. The AiCE Reconstruction Processing Unit uses AI to enhance and speed up the image reconstruction process, helping clinicians obtain clear and detailed MR images for diagnosis.

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 ACUSON Sequoia Diagnostic Ultrasound System family by Siemens Medical Solutions includes multi-purpose, software-controlled ultrasound systems designed to provide detailed images and measurements from inside the body. These systems support various clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging, among others. They assist clinicians by offering advanced imaging modes such as 2D, Doppler, elastography, and 3D/4D volume imaging, as well as specialized tools like Ultrasonically-Derived Fat Fraction (UDFF) for managing hepatic steatosis. The systems deliver real-time imaging and measurements to help diagnose and manage a wide range of conditions effectively.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a portable ultra-low field MRI device designed to image the internal structure of the head. It provides physicians with useful diagnostic images in environments where full diagnostic examination is not practical. The system uses deep learning reconstruction algorithms to improve image quality and is intended for use at the point of care, such as emergency rooms and intensive care units, enhancing access to MRI imaging in diverse clinical settings.

The O-arm O2 Imaging System by Medtronic Navigation, Inc is a mobile X-ray device designed to provide detailed 2D and 3D imaging of patients' bony anatomy and metallic objects, mainly used during image-guided surgeries. It includes advanced software features such as metal artifact reduction and dose reduction using machine learning, helping clinicians obtain clearer images with lower radiation exposure for improved surgical navigation and patient safety.

The Radiography 7300 C by Philips Medical Systems DMC GmbH is a stationary X-ray imaging system designed to capture high-quality radiographic images. It assists clinicians by providing detailed X-ray images that are essential for diagnosing various medical conditions involving the chest, bones, abdomen, and other body areas.

The uPMR 790 by Shanghai United Imaging Healthcare Co., Ltd. is a combined PET and MRI system that simultaneously captures high-resolution metabolic and anatomical images of the body to assist clinicians in diagnosis. It includes advanced AI-based image reconstruction and processing techniques, like DeepRecon for denoising and ACS for accelerated image reconstruction, improving image quality and scan efficiency without radiation exposure from MRI. This helps healthcare providers better assess physiological and anatomical conditions in patients.

The CT 5300 by Philips Healthcare is an advanced computed tomography system designed to produce detailed cross-sectional images of the head, body, cardiac and vascular structures. It supports various CT applications including diagnostic and low-dose lung cancer screening. The system uses AI-enhanced image reconstruction to provide high quality images at reduced radiation dose, helping clinicians detect and analyze anatomical features and abnormalities.

uMR Jupiter is a 5 Tesla superconducting MRI system developed by Shanghai United Imaging Healthcare Co., Ltd. It generates detailed anatomical and functional images of the head, body, and extremities to assist clinical diagnosis. The device features advanced AI-accelerated image reconstruction technology, enhancing image quality and scan speed, supporting clinicians in making accurate and timely diagnoses.

The Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 is a 1.5 Tesla magnetic resonance imaging (MRI) system developed by Canon Medical Systems. It incorporates AI-based technologies in its reconstruction processing unit (AiCE) to improve image quality, reduce scan time, and assist operators. This system aids clinicians by producing high-resolution images of anatomical structures of the head and body, facilitating accurate diagnosis and efficient workflow.