FDA Radiology AI Devices

NeuroMatch is a cloud-based medical software developed by LVIS Corporation to assist neurologists in reviewing and analyzing EEG recordings by automatically detecting potential seizures and epileptiform spikes. It employs advanced AI algorithms to highlight important EEG events, helping clinicians interpret brain activity more efficiently without providing a direct diagnosis.

RadUnity (Version 1.0.0) is a software device designed to centralize, manage, standardize, and network CT images using the DICOM protocol. It reformats CT medical images according to user-defined preferences to ensure consistent image formatting, thus supporting qualified radiology professionals in preparing images for interpretation. It is not intended for primary diagnostic review nor for mammographic image interpretation.

Transpara (2.1.0) is an AI software tool designed to assist doctors during screening mammography and digital breast tomosynthesis exams. It analyzes breast images to detect suspicious calcifications and soft tissue lesions and provides scores indicating the likelihood of cancer. This helps clinicians improve detection accuracy and workflow, but decisions should not be made solely on its output.

BriefCase-Quantification is an AI-based software that analyzes contrast-enhanced CT scans to measure aortic diameters at key anatomical landmarks, helping clinicians assess normal and aneurysmal aortas. It processes CT images in a cloud environment, produces measurement results for review, and is intended to assist but not replace radiologist evaluations.

The Dreem 3S is a wearable headband device that records brain electrical activity (EEG) and movement data during sleep. It uses AI algorithms based on neural networks to automatically analyze this data and produce detailed sleep stage reports for adults. This helps clinicians assess sleep patterns and disturbances remotely in home or healthcare environments.

The Gating Reflector Block is a reusable hardware accessory used during radiotherapy treatment and imaging to track patient respiratory motion. It helps monitor breathing patterns by reflecting infrared light detected by cameras in compatible radiation therapy and imaging systems, improving motion management during imaging or treatment delivery.

Jazz Classic is a dental imaging software that helps dental professionals capture, process, store, and review diagnostic dental images from various devices including intraoral x-ray sensors and scanners. It runs on standard PC hardware and assists clinicians in diagnosis and treatment planning by allowing image enhancement, annotation, and secure image management. This software supports both pediatric and general populations and integrates with dental practice management systems for improved workflow.

The SKR 3000 is a digital X-ray imaging system designed to replace traditional film/screen radiography in general diagnostic radiographic procedures. It uses an advanced flat-panel detector with antibacterial properties and wireless communication capabilities to capture detailed digital images of the human body, helping clinicians efficiently obtain and manage diagnostic images. This system is intended for adult use and excludes applications like mammography, fluoroscopy, and angiography.

Strain AI is a medical software device that analyzes cardiac ultrasound images to measure global longitudinal strain (GLS), helping clinicians assess heart function in adult patients. It integrates with existing ultrasound devices to provide quantitative strain measurements, supporting diagnostic evaluation without requiring manual interpretation of images.

The XENOVIEW 3.0T Chest Coil is a flexible MRI coil designed to work with 3.0T MRI scanners. It is intended for use with hyperpolarized xenon gas inhaled by patients to provide detailed MRI images of lung ventilation. This device helps clinicians evaluate lung function in adult and pediatric patients, enhancing pulmonary imaging capabilities with advanced MRI technology.