FDA Radiology AI Devices

The GT300 and GT300-C are dental computed tomography (CT) devices used in radiology to produce detailed X-ray images of the teeth and jaw. These devices assist clinicians in diagnosing and planning treatment by providing high-resolution images of dental structures.

The BONX805 is a mobile X-ray system designed for radiology applications. It helps clinicians by providing portable X-ray imaging capabilities, facilitating diagnostic imaging in various clinical settings where mobility is essential.

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.