FDA Radiology AI Devices

Accuro 3S is a portable diagnostic ultrasound imaging system designed for use by trained healthcare professionals in hospitals or clinics. It provides B-mode ultrasound imaging with an advanced AI-based software called SpineNav-AI that assists with musculoskeletal imaging of the lumbar spine, especially guiding neuraxial anesthesia procedures. This system enhances clinicians' ability to accurately visualize anatomical structures and guide needle placements safely and efficiently.

DEEPECHO is a cloud-based AI software for fetal ultrasound image analysis. It helps trained healthcare professionals detect important fetal views in ultrasound scans and suggests caliper placement for accurate biometric measurements like head circumference and femur length. The software supports real-time image streaming and exam management to improve fetal assessment during pregnancy between 14 and 41 weeks, aiding clinicians to make informed decisions efficiently.

The uMR Omega is a 3.0 Tesla superconducting MRI system designed to capture detailed anatomical and functional images of the head, body, and extremities. It supports various advanced imaging sequences and features, including new RF coils and enhanced image processing algorithms like SparkCo for artifact correction and Inline ECV for quantitative mapping. This device helps clinicians diagnose by providing high-quality images and assisting workflows such as breast biopsy and cardiac function analysis.

The EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced ultrasound systems designed for diagnostic imaging and fluid flow analysis across multiple body regions. They include an AI software feature called R-Trigger that detects R-wave peaks from cardiac cycles without requiring ECG input, aiding automated cardiac measurements to simplify and improve workflow for clinicians during transthoracic echo exams.

Synapse 3D Base Tools (V7.0) is advanced medical imaging software from FUJIFILM designed to assist trained professionals in reading, interpreting, reporting, and planning treatment using images from various modalities such as CT, MRI, X-ray, ultrasound, and nuclear medicine. It provides powerful 3D viewing tools, image fusion, segmentation powered by deep learning, and supports multiple modalities and anatomical regions, which enhances diagnostic workflows and treatment planning for adult patients.

The Swoop® Portable MR Imaging® System is a portable, ultra-low field MRI device that produces images of the internal structure of the head. It incorporates a deep learning-based image reconstruction algorithm to enhance image quality, helping healthcare providers diagnose patients at the point of care, especially where full diagnostic exams are not practical.

InVision Precision Cardiac Amyloid is a software tool that uses machine learning to analyze echocardiogram videos and identify signs of cardiac amyloidosis in patients aged 65 and older. It integrates with existing hospital imaging systems and helps physicians screen patients by providing decision support alerts to guide referrals for further confirmatory tests.

SMARTDent is a software solution developed by RAY Co., Ltd. that helps dental professionals manage and analyze various types of dental imaging, including CT, panoramic, cephalometric, and intraoral X-rays. It streamlines image management and provides tools that support diagnosis, thereby assisting clinicians in dental care.

The HJY VisualNext 3D Endoscopic Vision System is a medical device designed to provide surgeons with a 3D visual of internal surgical sites during neurological, spinal, and general surgeries. It uses dual CMOS sensors and integrated LED lighting to capture and display high-resolution 3D images on an external monitor, helping clinicians better visualize the surgical area for improved precision and outcomes.

SCENARIA View Phase 5.0 is a multi-slice CT system that acquires axial volumes of the whole body in various scan modes. It includes AI-based features such as AutoPose that automatically recognizes and sets scan ranges for body parts, improving workflow and scan accuracy. The system supports high-quality imaging with motion correction and provides enhanced post-processing capabilities to assist clinicians in diagnosis and interventional guidance.