FDA Radiology AI Devices

This product consists of ultrasonic probes used in diagnostic imaging. These probes emit and receive ultrasound waves to create images of the body's internal structures, helping clinicians visualize and assess patients non-invasively.

The syngo.via MI Workflows, including Scenium and syngo MBF, are Siemens software tools designed to assist radiologists by automating the processing of medical images, improving workflow efficiency and potentially supporting diagnosis through advanced image analysis.

The Mendaera Guidance System is an ultrasonic diagnostic transducer designed to assist clinicians in medical imaging procedures by providing real-time ultrasound images. It helps healthcare providers visualize internal structures, aiding in diagnosis and treatment guidance.

The OPUSWAVE Dual Sensor Imaging System is a medical device that uses Optical Coherence Tomography to capture detailed images of cardiovascular structures. It helps clinicians by providing high-resolution imaging to assist in diagnosis and treatment of cardiovascular conditions.

The RadiForce RX570 and RX570-AR are high-resolution color LCD monitors designed for viewing medical images, including mammography and digital breast tomosynthesis. These monitors provide calibrated display modes ensuring consistent, high-quality images for radiologists, aiding in accurate image review, analysis, and diagnosis. The devices come with quality control software to support reliable monitor calibration and performance verification.

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.

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.

The Natus BrainWatch System is a portable EEG monitoring device that records and visually presents EEG signals to assist trained medical personnel in neurological diagnosis for patients aged 2 years and older. It features a disposable headband with integrated electrodes, wireless connectivity, and cloud storage, enabling rapid and convenient EEG monitoring in healthcare settings.

The VIVIX-S 1751S is a digital flat panel X-ray detector designed for general-purpose diagnostic radiographic procedures. It replaces traditional film/screen X-ray systems by capturing and converting X-ray photons into digital images. This helps clinicians obtain high-quality digital X-ray images quickly and efficiently for better diagnosis.