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.

SubtleHD (1.x) is an AI-based image processing software designed to enhance MRI images from any body part. It improves image quality by reducing noise and increasing sharpness, helping radiologists obtain clearer images without changing the original scan process. This facilitates improved diagnostic confidence and visualization of anatomical structures.

SureWave Elastography is an accessory device for Siemens MRI systems that generates shear wave vibrations during MRI scans to create images showing tissue stiffness. This advanced imaging helps physicians diagnose tissue abnormalities by providing detailed stiffness maps alongside traditional MRI images.

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.

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.

Ultrasound Workspace (UWS 6.0) is a clinical software package from Philips designed for analyzing and quantifying ultrasound images of cardiovascular, fetal, and abdominal structures. Using AI and machine learning, it supports physicians in diagnosing conditions by automating the measurement of heart functions, valve anatomy, and blood flow dynamics. This helps improve efficiency and accuracy in interpreting ultrasound exams, particularly in adult cardiac applications.

Identify (4.0) is a medical device by Varian Medical Systems designed to monitor patient motion and respiratory patterns during radiotherapy treatment simulation and delivery. Using high precision surface guided radiation therapy cameras, it helps clinicians accurately position patients and detect motion during treatment, enhancing patient safety and treatment accuracy by synchronizing imaging and radiation delivery with patient motion data.

The EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced diagnostic ultrasound devices that use AI-powered AutoMeasure V3 software to provide semi-automated 2D, Doppler, and M-mode measurements for adult echocardiography. These systems help healthcare professionals efficiently perform and analyze cardiac ultrasound exams, improving measurement accuracy and workflow in clinical environments such as hospitals and clinics.

BoneMetrics (US) is an AI-powered software that automatically measures Cobb angles on frontal spine x-rays to assist healthcare professionals in evaluating spinal deformities such as scoliosis. It integrates with existing imaging systems to provide quantitative angle measurements that can support clinical decision-making, improving workflow efficiency and consistency.

rTOP is a teleoperation platform that allows medical professionals to remotely operate, assist, review, monitor, and standardize medical imaging and diagnostic devices. It supports video and USB interfaces for human interface devices, enabling read-only or full access control to these devices. The system facilitates remote collaboration and training across healthcare sites, helping clinicians efficiently share expertise and improve workflow, even when not physically present with the imaging equipment.