FDA Radiology AI Devices

The Readius series (L15, P8, V6, C6) are digital color Doppler ultrasound imaging systems designed for diagnostic use by qualified physicians. They support various scanning modes to image abdominal areas, small organs like the thyroid and breast, and peripheral vascular structures. The systems enable B-mode, M-mode and advanced Doppler flow imaging to assist clinicians in evaluating blood flow and tissue characteristics in real time.

The Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device designed to photograph, display, and store images of the retina under non-mydriatic conditions. It aids clinicians in the evaluation, diagnosis, and documentation of ocular health by providing high quality retinal images.

The MC2 Portable X-ray System by Oxos Medical is a handheld, portable X-ray device intended to help clinicians perform point-of-care imaging of joint and bone areas (extremities) outside of surgery. It uses advanced technologies including infrared tracking and LIDAR to position and ensure safe operation, producing high-quality images in single radiography, serial radiography, and fluoroscopic modes. The device connects wirelessly to tablets or monitors for image review and facilitates efficient orthopedic imaging in various clinical settings.

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.

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.

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 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.

The PRORAD X-Ray Flat Panel Detector with DROC is a digital radiography system designed to capture and display X-ray images of human anatomy. It is intended for general projection radiographic applications and helps clinicians by digitizing X-ray images for faster, more flexible image viewing and processing. The detector incorporates software that supports image workflow, viewing, measurement, and DICOM connectivity, streamlining radiographic exams and image management in clinical settings.