FDA Radiology AI Devices

The Behold.ai Red Dot device is an AI-powered software platform that assists radiologists by automatically analyzing adult chest X-ray images to identify suspected pneumothorax cases. It integrates into clinical workflows by notifying radiologists through PACS or workstation systems to prioritize these cases for faster review. It is intended to support, but not replace, clinical decision-making.

The Aquilion Prime SP V10.2 with AiCE-i is an advanced CT imaging system that uses artificial intelligence through Deep Convolutional Neural Networks to reduce image noise and improve image clarity. This system helps clinicians capture better quality whole-body CT scans, including the head, optimizing image quality and potentially reducing radiation dose for patients.

Densitas densityai is a software application that analyzes digital mammography and breast tomosynthesis images to automatically assess breast tissue density. It provides a Breast Density Grade according to the American College of Radiology's BI-RADS 5th Edition to assist physicians in evaluating breast composition. This adjunctive tool helps interpret breast density consistently and efficiently, enhancing clinical decision-making in breast cancer screening.

The Biograph Vision and Biograph mCT PET/CT systems from Siemens are advanced imaging machines that combine CT and PET technologies to produce high-resolution images showing both anatomical structures and physiological functions. These systems help healthcare professionals detect, localize, diagnose, and stage various diseases including cancer, cardiovascular, and neurological disorders, and also assist with radiotherapy and interventional procedures.

The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is a whole-body multi-slice helical CT scanner. It captures high-quality cross-sectional volume images of whole organs in a single rotation. It includes advanced AI algorithms—AiCE for noise reduction using Deep Convolutional Neural Networks and FIRST iterative reconstruction to improve image quality and reduce radiation dose. It supports spectral imaging with rapid kV switching to differentiate material composition in tissues, aiding clinicians in diagnosis and treatment planning.

The Biograph Horizon is a medical imaging system that combines positron emission tomography (PET) and computed tomography (CT) to provide detailed metabolic and anatomical images of the body. It helps clinicians in detecting, diagnosing, and monitoring diseases such as cancer, cardiovascular, and neurological disorders by fusing high-resolution functional and anatomical data, thereby improving treatment planning and clinical decision-making.

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, and Halcyon are integrated tools designed to help clinicians manage, plan, and deliver radiation therapy treatment. The software supports radiation therapy plan management and adaptive treatment planning, while the radiotherapy systems deliver precise radiation treatment using image guidance to treat lesions and tumors anywhere in the body. These tools aim to improve the accuracy and effectiveness of radiotherapy for patients, including adults and pediatric patients.

Caption Guidance is an AI software accessory for ultrasound systems that helps clinicians, including those without specialized training, acquire high-quality cardiac ultrasound images. It provides real-time feedback and prescriptive guidance to optimize the capture of diagnostic standard 2D echocardiographic views, supporting quicker and more reliable heart assessments.

MRCAT brain is a software add-on for Philips Ingenia MR systems that generates CT-like images from MR scans to assist in radiation therapy treatment planning for brain tumor patients. It helps clinicians by providing detailed tissue density maps necessary for accurate radiation dose calculations without the need for a separate CT scan.

Auto Positioning is a feature for GE CT systems that streamlines and automates patient positioning for CT exams by using a 2D/3D video camera and AI (deep learning) to determine anatomical landmarks, patient orientation, and optimal table position. This helps technologists position patients accurately and safely, improving image quality and workflow efficiency.