FDA Radiology AI Devices

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.

The ACUSON Sequoia, Sequoia Select, and Origin are advanced multi-purpose diagnostic ultrasound systems by Siemens, designed for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, and musculoskeletal imaging. They incorporate AI-based software applications (AI Measure, AI Assist, 2D HeartAI, 4D HeartAI) to assist clinicians in cardiac imaging by automating measurements, image annotation, and analysis, thereby improving workflow and diagnostic confidence.

Denti.AI Detect is a computer-assisted detection software designed for dental professionals to assist in identifying dental issues such as caries and periapical radiolucency on 2D dental X-rays. It also helps measure bone levels around teeth, serving as a second reader to improve diagnostic accuracy and support clinical decisions.

DeepTek CXR Analyzer v1.0 is a software tool that helps radiologists detect suspicious regions in chest X-rays. Using AI and deep learning, it highlights abnormal areas related to lungs, pleura, heart, and hardware implants to support clinicians in their diagnosis. It doesn't replace radiologists but acts as an aid to improve detection accuracy and efficiency.

cmAngio V1.0 is an AI-powered software designed to assist radiologists by automatically processing radiological images, helping to improve diagnostic efficiency and accuracy.

Lung-CAD is an AI-based software designed to assist physicians by analyzing chest X-ray images and identifying regions of lung hyperinflation. It highlights these regions with boxes on the X-ray images to support concurrent reading, improving detection accuracy without replacing clinical diagnosis.

HipCheck is a software tool used during hip arthroscopy surgeries that helps surgeons measure the alpha angle related to femoroacetabular impingement (FAI). It processes X-ray images taken during surgery and overlays virtual measurement tools on these images to support clinical decision-making. It also includes a patient-specific report feature for preoperative planning using three-dimensional analyses and visualizations of the hip.