FDA Radiology AI Devices

The Clarius Ultrasound Scanner is a portable, wireless ultrasound imaging system designed for diagnostic use across multiple body regions. It connects via Wi-Fi to mobile devices, allowing healthcare professionals to visualize real-time, high-resolution ultrasound images and fluid flow analysis in diverse clinical applications such as fetal, abdominal, cardiac, musculoskeletal, and more. This device facilitates medical imaging in varied clinical environments by enabling image acquisition on tablets and smartphones.

Venue is a general-purpose diagnostic ultrasound system designed for use by qualified healthcare professionals in various clinical settings including critical care, emergency rooms, and outpatient offices. It supports multiple ultrasound imaging applications for different body regions, facilitating imaging, measurement, and analysis of human body structures and fluid, thereby aiding clinical diagnosis and interventional procedures.

The DR 800 with MUSICA Dynamic by Agfa HealthCare is an advanced fluoroscopic X-ray system designed for dynamic imaging of various body parts, such as gastrointestinal and urogenital tract examinations and angiography. It replaces traditional image intensifier technology with flat-panel digital detectors and incorporates MUSICA Dynamic software for enhanced image processing, improving image quality and aiding clinicians in accurate diagnosis while supporting pediatric and adult imaging needs.

iQMR is a software package designed to enhance MRI images by reducing noise and improving image quality. It operates on a PC server connected to a network, receiving and transmitting MRI images in DICOM format. This helps medical professionals get clearer images for better diagnosis and analysis.

The UNiD Spine Analyzer is a software tool that helps healthcare professionals view, measure, and analyze medical images related to the spine. It assists in planning orthopedic surgeries by allowing surgeons to perform measurements and plan the placement of surgical implants. This tool enhances surgical planning accuracy and efficiency for spine treatments.

The Illumeo System by Philips Medical Systems Technologies Ltd. is a software platform designed for trained professionals such as radiologists. It manages, processes, and displays medical images and associated patient data from various imaging modalities, supporting visualization, measurements, and tracking changes over time. It enhances workflow through integration with clinical systems and provides advanced viewing tools including 2D/3D views and enterprise web viewers, helping clinicians efficiently interpret imaging studies.

Infinitt PACS 7.0 is a software system designed to store, process, and display medical images across multiple imaging sources. It allows clinicians to view and manipulate images for diagnosis using advanced tools like 3D visualization, hanging protocols, and secure network features, enhancing access to diagnostic information from anywhere via a web interface.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system designed for diagnostic imaging and fluid flow analysis across a broad range of clinical applications including ophthalmic, fetal, abdominal, cardiac, musculoskeletal, and more. It wirelessly connects to iOS or Android devices, enabling clinicians to acquire high-resolution real-time ultrasound images and Doppler flow data for enhanced diagnostic evaluation and procedural guidance.

The syngo Application Software by Siemens is a versatile medical imaging software that allows clinicians to view, manipulate, and process medical images in real time. It supports diagnostic image review and various interventional procedures by providing image-guided navigation, fusion of ultrasound with fluoroscopy, and 3D visualization to improve anatomical orientation and procedural accuracy. This software helps clinicians streamline complex procedures and enhances treatment planning and control.

SmartTarget is a software system designed to assist physicians during image-guided prostate procedures by enhancing visualization. It processes 2D transrectal ultrasound images by performing 3D reconstruction and fusing these images with diagnostic scans like MRI or CT. This helps doctors accurately target and navigate instruments during biopsies, ablations, and other treatments, improving procedure precision and patient outcomes.