FDA Radiology AI Devices

The Ultrasound System 1300 by BK Medical ApS is a mobile ultrasound system designed for diagnostic imaging and fluid flow analysis across multiple clinical applications including fetal, abdominal, neuro, musculoskeletal, and vascular imaging. It aids clinicians by providing advanced imaging modes and AI software features like Prostate Volume Assist for workflow improvement and accurate prostate volume measurements.

Sonix Health is a software product that assists clinicians in analyzing adult echocardiography ultrasound images. It uses artificial intelligence to automatically classify ultrasound views, segment anatomy, and perform semi-automated measurements, helping physicians quantify cardiac function more efficiently. The software generates reports based on B-mode, M-mode, and Doppler ultrasound images and supports manual verification and adjustment of AI results.

Veuron-Brain-pAb3 is advanced software that processes PET and MRI brain images to help clinicians detect and quantify amyloid protein concentration as an aid in diagnosing dementia. It automates image registration, fusion, and calculates standard uptake value ratios (SUVR) to visualize and analyze brain pathologies, improving diagnostic accuracy and workflow efficiency.

SpotLight/SpotLight Duo (with DLIR option) is a CT scanner that produces cross-sectional images of the body, including cardiovascular and thoracic anatomies. It uses a dual-tube CT system and advanced deep learning reconstruction to enhance image quality while reducing noise. This helps clinicians obtain clearer diagnostic images for disease detection and therapy planning.

The NeuViz 128 Multi-Slice CT Scanner System by Neusoft Medical Systems is a CT scanner designed for whole body imaging, producing cross-sectional images to help clinicians diagnose various medical conditions. It incorporates advanced AI-powered reconstruction methods to reduce noise and enhance image quality, potentially lowering radiation dose for patients while improving diagnostic capabilities.

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.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a portable, ultra-low field MR imaging device designed to produce images of the internal structures of the head. It uses deep learning algorithms to improve image quality by reducing noise and blurring, helping clinicians at the point of care obtain diagnostic information even when full diagnostic exams are impractical.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound device that wirelessly connects to iOS or Android devices to provide real-time, high-resolution diagnostic ultrasound images across many clinical applications such as cardiac, abdominal, pediatric, and musculoskeletal imaging. It helps healthcare professionals by offering dual-array transducer functionality in a single device, enhancing convenience and efficiency during ultrasound exams.

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

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.