FDA Radiology AI Devices

Videa Dental Assist is an AI-powered software that analyzes intraoral dental X-ray images such as bitewing, periapical, and panoramic radiographs. It assists dental professionals by automatically detecting and localizing suspected dental findings, historical treatments, and normal anatomical features, helping improve diagnostic accuracy and patient management.

DTX Studio Clinic (4.0) is a dental and craniomaxillofacial imaging software that assists clinicians by analyzing 2D intraoral radiographs with AI to detect dental issues such as caries, calculus, and bone loss. It supports diagnostic workflows and treatment planning, including guided implant surgery, by managing and enhancing images from various sources and facilitating image sharing and review.

The Aquilion Serve SP (TSX-307B/1) V1.3 is a multi-slice helical CT scanner that acquires and displays whole-body cross-sectional imaging volumes. It includes an AI-based noise reduction algorithm called AiCE (Advanced Intelligent Clear-IQ Engine) that enhances image quality by reducing noise using deep learning techniques. This helps clinicians obtain clearer diagnostic images for various applications including abdomen, pelvis, lung, cardiac, extremities, head, and inner ear imaging.

Adravision Perio is a semi-automated dental image processing software that assists dentists and dental hygienists in measuring mesial and distal bone levels from bitewing and periapical radiographs. The software provides suggested measurements and visual annotations to support clinical decision-making, improving the accuracy and efficiency of dental assessments for adults without primary teeth.

AI Platform (AIP001) by Exo Inc is a software tool designed to help medical professionals assess ultrasound images of the heart and lungs in adult patients. It uses AI to detect and measure features of these images, aiding in quantification and reporting of important clinical parameters such as ejection fraction and lung artifacts, thus supporting diagnosis and treatment decisions in a clinical setting.

BriefCase-Quantification is an AI-powered software that automatically measures brain midline shift in non-contrast head CT scans, assisting medical specialists by automating a typically manual measurement process. It provides quantitative analysis and comparative reports over time to help clinicians monitor patients, without altering original images or serving as a standalone diagnostic tool.

BriefCase-Quantification is an AI-powered radiological image management and processing software that analyzes contrast-enhanced CT images to measure the maximum axial diameter of the abdominal aorta. It assists trained medical specialists by providing preliminary measurements to help evaluate normal and aneurysmal abdominal aortas. The tool outputs annotated preview images, which serve as unofficial measurements to aid clinical review, with final decisions left to radiologists.

The LOGIQ E10s and LOGIQ Fortis are advanced general-purpose diagnostic ultrasound systems designed for use by trained healthcare professionals. They provide high-resolution ultrasound imaging and measurements across a wide range of clinical applications, including obstetrics, abdominal, cardiac, vascular, musculoskeletal, and intraoperative imaging. The systems incorporate various imaging modes such as Doppler, elastography, 3D/4D imaging, and AI-powered assistant features to enhance workflow and diagnostic accuracy, thereby assisting clinicians in evaluating and analyzing human body structures and fluids effectively.

LOGIQ E10 is a general-purpose diagnostic ultrasound imaging system designed for use by qualified physicians. It supports multiple ultrasound modes such as B-mode, Doppler imaging, harmonic imaging, elastography, and 3D/4D imaging, providing digital image acquisition and processing. The system includes AI-powered features like Auto Renal Measure Assistant and Auto Abdominal Color Assistant to assist clinicians by automating measurements and suggesting anatomical views, thus improving workflow efficiency and diagnostic accuracy.

Lunit INSIGHT DBT is an AI-powered software designed to assist physicians in detecting and characterizing suspicious lesions for breast cancer in digital breast tomosynthesis (DBT) images. It analyzes DBT scans to identify and highlight regions of soft tissue lesions and calcifications with scores indicating malignancy likelihood, thereby supporting better screening and diagnosis of breast cancer in women.