FDA Radiology AI Devices

This product is a family of Philips MRI systems designed to produce detailed images of the body's internal structures. These MRI machines help doctors and clinicians by providing high-quality images that assist in diagnosing a variety of medical conditions across different body regions without using ionizing radiation.

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.

Constellation (CON-001) is an automated software tool that processes whole-body MRI images to segment anatomical regions and quantify various tissues such as muscles, fat, and organs. It provides clinicians with detailed quantitative reports with visual overlays to support clinical decisions without making autonomous diagnoses, focusing on healthy adult patients.

TRAQinform IQ is a cloud-based software tool designed to aid medical professionals by providing quantitative analysis of lesions identified in PET/CT scans. It uses AI techniques such as machine learning for anatomical and skeletal segmentation and automates matching and quantitative assessment of regions of interest between multiple scans. The device generates detailed reports on lesion volume and tracer uptake changes over time, supporting clinicians in oncology and nuclear medicine to monitor disease progression and treatment response.

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 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.

YSIO X.pree is a digital stationary X-ray system designed to create X-ray images of various body parts including the skull, chest, abdomen, and extremities. It helps medical professionals visualize anatomical structures to support diagnosis and treatment. The system features updated software, new wireless detectors, and AI-based functions like auto-cropping and automatic collimation to improve image quality and ease of use.

The ECHELON Synergy V10.0 MRI system by Fujifilm Healthcare Americas Corporation is an advanced magnetic resonance imaging device that produces detailed cross-sectional images of the body using non-ionizing magnetic fields. It helps physicians diagnose various conditions by providing high-quality images reflecting tissue properties such as proton density and relaxation times. This system includes updated software features with AI-powered image processing to improve image quality and workflow efficiency, benefiting both clinicians and 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.