FDA Radiology AI Devices

AspenView is a software designed to assist radiologists and radiology technicians in annotating, processing, and managing general radiographic X-ray images. It supports standard medical image formats and provides functions such as image stitching, storage, and transmission, helping clinicians handle and review X-ray images efficiently.

The Vivid iq is a high-performance compact diagnostic ultrasound system designed primarily for cardiovascular and shared services imaging, but also applicable to various clinical areas such as fetal, abdominal, pediatric, musculoskeletal, and vascular imaging. It supports multiple ultrasound modes including Doppler and real-time 3D imaging. The system aids healthcare professionals by providing advanced ultrasound imaging and analysis capabilities for better diagnosis and patient care.

The Vivid T9/Vivid T8 is a diagnostic ultrasound system primarily intended for cardiac imaging but also supports vascular and general radiology applications. It provides digital acquisition, processing, measurement, display, and analysis of ultrasound images using various transducers and imaging modes. The system supports a range of clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging, helping healthcare professionals in hospitals and clinics obtain real-time detailed images for diagnostic purposes.

ZeTTA PACS is a software system designed for hospitals and diagnostic centers to receive, store, retrieve, and display medical images from various modalities such as CT, MRI, ultrasound, and X-ray. It helps healthcare professionals securely access and analyze diagnostic images over hospital networks, supporting efficient image interpretation and management but does not provide diagnostic decision-making functions.

The Ziehm Vision RFD 3D is a medical imaging device that provides high-quality 2D and 3D fluoroscopic X-ray images during surgical and diagnostic procedures. It helps clinicians visualize complex anatomical structures such as bones, joints, and soft tissues in real-time, improving outcomes in orthopedic, neurological, trauma, and other surgeries. The system supports computer-assisted surgery by providing detailed imaging and C-arm positioning data, facilitating safer and more accurate interventions.

VIVIX-M is a series of advanced flat panel detectors designed for digital mammography. These detectors capture high-quality digital X-ray images of the breast to assist clinicians in screening and diagnosing breast conditions. The system processes the X-ray signals into detailed digital images compatible with medical imaging workflows, supporting effective and accurate mammography examinations.

Cardiac Guidance software helps medical professionals capture standard cardiac ultrasound views by providing real-time AI-powered guidance, quality feedback, and automatic image capture during echocardiography. It supports better image acquisition for accurate cardiac assessment, assisting clinicians during ultrasound exams.

The Ziehm Vision RFD is a mobile fluoroscopy system with a flat panel detector used to provide real-time digital imaging during diagnostic and interventional surgical procedures. It helps clinicians visualize complex anatomical structures in various body regions including the spine, joints, and cardiovascular system, aiding in procedures such as cardiology, orthopedics, neurology, and more. The device offers advanced digital subtraction and cine imaging, enhancing image quality and surgical navigation accuracy to improve clinical outcomes for patients.

SpectoMed (v1.0) is a software tool for medical professionals that enables real-time 3D visualization and analysis of CT and MRI images. It supports virtual and augmented reality interfaces to aid clinicians in preoperative planning and during surgery by providing realistic spatial views of patient anatomy along with measurement tools, enhancing diagnostic assessment and surgical preparation.

The Orthoscan VERSA Mini C-Arm is a mobile fluoroscopic X-ray system designed to provide real-time imaging for diagnostic, surgical, and emergency procedures, particularly focused on limbs, extremities, and shoulders. The system enhances clinical workflow by delivering high-quality fluoroscopic images with improved ergonomics and efficiency, helping clinicians to visualize anatomy during treatment.