FDA Radiology AI Devices

This product is a series of diagnostic ultrasound systems used to capture real-time images of the body's internal structures, helping clinicians diagnose and monitor various medical conditions. It supports multiple models designed for different imaging needs and clinical environments.

The ACUSON Sequoia and ACUSON Origin Diagnostic Ultrasound Systems by Siemens are advanced ultrasound imaging devices used by clinicians to visualize internal structures of the body in real-time. They help in diagnosing a variety of conditions by providing high-quality ultrasonic images, aiding patient care through non-invasive and versatile imaging.

The Vantage Fortian/Orian 1.5T from Canon Medical Systems is an MRI system enhanced with the AiCE Reconstruction Processing Unit. It uses AI technology to improve image reconstruction, assisting clinicians in obtaining high-quality magnetic resonance images for diagnosis.

The Yushan X-Ray Flat Panel Detector is a digital imaging device designed to capture high-quality X-ray images for radiology. It helps clinicians obtain clear diagnostic images efficiently, supporting better patient diagnosis and care.

The uMI Panvivo is a system for performing computed emission tomography, which helps clinicians visualize and analyze internal structures in the body for diagnostic purposes. It supports advanced imaging techniques to assist medical professionals in detecting and assessing diseases.

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.

The Philips iCT CT System is a computed tomography scanner designed for diagnostic imaging of the head, body, cardiac, and vascular regions. It produces detailed cross-sectional images by reconstructing X-ray data taken from multiple angles, aiding clinicians in diagnosing a range of conditions. The system offers updated hardware and software improvements for enhanced image quality, cybersecurity, and usability without altering its core imaging capabilities.

The MAGNETOM Avanto Fit, MAGNETOM Skyra Fit, MAGNETOM Sola Fit, and MAGNETOM Viato.Mobile are MRI systems designed to produce detailed diagnostic images and spectra of the head, body, and extremities. They include advanced AI-based features such as Deep Resolve Boost and Deep Resolve Sharp to enhance image quality and speed, aiding radiologists in diagnosis and treatment planning.

MAGNETOM Flow.Ace and MAGNETOM Flow.Plus are advanced 1.5T MRI systems by Siemens that produce high-resolution images of the head, body, or extremities, using MR technology and optional local coils. Equipped with AI-powered software features such as Deep Resolve for image enhancement and AutoMate Cardiac for cardiac imaging automation, these devices help clinicians obtain detailed diagnostic images efficiently and safely, facilitating diagnosis and interventional procedures.